FrancophonIA/ELRC3.0 huggingface dataset:
English: Medium 199 containing principally amino acids, mineral salts, vitamins
Maltese: Medium 199 li fih prinċipalment amino acids, mineral salts, vitamini
English: Very common: crying abnormal, irritability, restlessness Uncommon: nervousness
Maltese: Komuni ħafna : biki mhux normali, irritabilita', nuqqas ta' sabar Uncommon : nervożita'
English: months N=554
Maltese: xhur N=554
English: 8 micrograms 10 micrograms
Maltese: 8 mikrogrammi 10 mikrogrammi
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C)
English: 1adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Maltese: 1adsorbit fuq aluminium hydroxide idradat (Al(OH)3)
English: months N= 326
Maltese: xhur N= 326
English: FI.PT@gsk.com
Maltese: es-ci@gsk.com
English: ND 99.6
Maltese: ND 99.6 ND 97.1 ND 99.6
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA12
Maltese: Grupp farmako-terapewtiku: vaċċini batterjali u virali flimkien, ATC kodiċi JO7CA12
English: 40 D-antigen unit
Maltese: 40 unita' ta' D-antiġen
English: • feeling nervous.
Maltese: • tħossok nervuż
English: EU/1/00/153/001 - 1 pre-filled syringe without needle EU/1/00/153/002 - 10 pre-filled syringes without needles EU/1/00/153/003 - 20 pre-filled syringes without needles EU/1/00/153/004 - 50 pre-filled syringes without needles EU/1/00/153/005 - 1 pre-filled syringe with 1 needle EU/1/00/153/006 - 10 pre-filled syringes with 10 needles EU/1/00/153/007 - 20 pre-filled syringes with 20 needles EU/1/00/153/008 - 50 pre-filled syringes with 50 needles EU/1/00/153/009 - 1 pre-filled syringe with 2 needles EU/1/00/153/010 - 10 pre-filled syringes with 20 needles
Maltese: EU/1/00/153/001 - 1 siringa mimlija lesta mingħajr labra EU/1/00/153/002 - 10 siringi mimlijin lesti mingħajr labar EU/1/00/153/003 - 20 siringa mimlijin lesti mingħajr labar EU/1/00/153/004 - 50 siringa mimlijin lesti mingħajr labar EU/1/00/153/005 - 1 siringa mimlija lesta b'labra 1
English: HIV infection is not considered as a contraindication.
Maltese: Infezzjoni ta' HIV m'hiex meqjusa bħala kontraindikazzjoni.
English: Booster vaccination:
Maltese: Tilqim booster:
English: The clinical protection of the pertussis component of Infanrix, against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated in:
Maltese: Il-protezzjoni klinika tal-komponent ta' pertussis ta' Infanrix, kontra s-sogħla konvulsiva tipika kif deskritta mill-WHO (≥ 21 ġurnata ta' attakki ta' sola) ġiet osservata fi:
English: 0.2 milligrams Al3+
Maltese: 0.2 milligrammi Al3+
English: • Hepatitis B - is caused by the hepatitis B virus.
Maltese: • Epatite B: hija kkawżata mill-virus tal-epatite B.
English: not less than 30 IU not less than 40 IU
Maltese: mhux anqas minn 30 IU mhux anqas minn 40 IU
English: † cut-off accepted as indicative of protection
Maltese: † cut-off aċċettata bħala indikazzjoni ta' protezzjoni
English: Infanrix Penta, Suspension for injection
Maltese: Infanrix Penta - Suspensjoni għall-injezzjoni
English: 8 D-antigen unit 32 D-antigen unit
Maltese: 8 unita' ta' D-antiġen 32 unita' ta' D-antiġen
English: 0.5 milligrams Al3+ 0.2 milligrams Al3+
Maltese: 0.5 milligrammi Al3+ 0.2 milligrammi Al3+
English: After vaccination with 3 doses (e.g. 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose and preferably before 18
Maltese: Wara tilqima bi tlett dożi (e.ż. 2, 3, 4 xhur; 3, 4, 5 xhur; 2, 4, 6 xhur) ta' Infanrix Penta għandha tinghata doża booster almenu 6 xhur wara l-aħħar doża primarja u preferibbilment qabel l-eta' ta 18-il
English: - a prospective blinded household contact study performed in Germany (3, 4, 5 months schedule).
Maltese: - Studju prospettiv u blinded li sar fuq familji fil-Ġermanja (skeda ta' 3,4,5 xhur).
English: In extremely rare cases, paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported.
Maltese: F'każijiet rari ħafna ġew irrappurtati paraliżi, newropatija, s-sindromu ta' Guillain-Barre, enkefalopatija, enkefalite u meninġite.
English: • Infanrix Penta is available in packs of 1, 10, 20 and 50 with or without needles.
Maltese: • Infanrix Penta jinstab f`pakketti ta' 1, 10, 20 u 50 bil-labar jew mingħajr labar.
English: Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Maltese: Infanrix Penta, Suspensjoni għall-injezzjoni Vaċċin (adsorbit) għad-difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV).
English: The safety profile presented below is based on data from more than 10,000 subjects.
Maltese: Il-profil ta' sigurta' ippreżentat hawn taħt huwa bbażat fuq data minn aktar minn 10,000 suġġett.
English: Date of latest renewal: 23 October 2005
Maltese: Data ta' l-aħħar tiġdid: 23 ta' Ottubru 2005
English: Psychiatric disorders:
Maltese: Disturbi psikjatriċi :
English: The vaccine efficacy was found to be 84%.
Maltese: Instab li leffikaċja tal-vaċċin kienet ta' 84%.
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Maltese: Vaċċin (adsorbit) għad-difterite (D), tetnu (T), sogħla konvulsiva (partijiet taċ-ċellula, komponent) (Pa), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV).
English: - Tabulated summary of adverse reactions (clinical trials):
Maltese: Sommarju f'forma ta' tabella tar-reazzjonijiet avversi (provi kliniċi);
English: HHOW TO STORE INFANRIX PENTA
Maltese: Infanrix Penta
English: The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections.
Maltese: Is-sustanzi l-oħra f'Infanrix Penta huma: sodium chloride (NaCl), medium 199 li fih prinċipalment amino acids, mineral salts, vitamini u ilma għall-injezzjonijiet
English: Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90% of children administered four doses of a combined vaccine containing the same HBs antigen as Infanrix Penta.
Maltese: Antikorpi prottettivi kontra l-epatite B dehru li ppersistew mill-anqas 3.5 snin f'aktar minn 90% ta' tfal li ħadu erba' dożi ta' vaċċin kombinat li fih l-istess antiġen HB bħal Infanrix Penta.
English: The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months).
Maltese: L-iskeda ta' tilqim primarju tikkonsisti fit-tlett dożi ta' 0.5ml (bħal 2, 3, 4 xhur; 3, 4, 5 xhur; 2, 4, 6 xhur) jew żewġ dożi (bħal 3, 5 xhur).
English: However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 months schedule.
Maltese: Madankollu, d-data tindika li l-protezzjoni kontra l-pertussis tista' tkun qed tmajna bejn l-eta' ta' 7-8 snin b'din l-iskeda ta 3-5-12 xhur.
English: Pack sizes of 1, 10, 20 and 50 with or without needles.
Maltese: Pakketti ta' 1, 10, 20 u 50 bil-labar jew mingħajr labar.
English: Very common: fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain, redness Common: fever >39.5°C, local swelling at the injection site (> 50 mm)*, injection site reactions,
Maltese: Komuni ħafna: deni ≥ 38˚C, nefħa fis-sit tat-tilqima (≤ 50 mm), għejja, uġigħ, ħmura Komuni: deni > 39.5˚C, nefħa fis-sit tat-tilqima (> 50 mm)*, reazzjonijiet fis-sit ta' l-injezzjoni, li jinkludu egħbusija.
English: Infanrix Penta will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus or poliovirus.
Maltese: Infanrix Penta ma tipprevjenix mard ikkawżat minn mikrobi ħlief għal Corynebacterium diphtheriae, Clostridium tetani, Bordatella pertussis, il-vajrus ta' l-epatite B jew il-vajrus tal-polio.
English: 10 x 1 dose (0.5 ml) 20 pre-filled syringes 20 x 1 dose (0.5 ml)
Maltese: 10 x 1 doża (0.5 ml) 20 siringa mimlijin lesti 20 x 1 doża (0.5 ml) 50 siringa mimlijin lesti 50 x 1 doża (0.5 ml)
English: (5 EL.U/ml) Anti-PRN (5 EL.U/ml) Anti-HBs (10 mIU/ml) † Anti-Polio type 1 (1/8 dilution) †
Maltese: Anti-PT (5 EL.U/ml) Anti-FHA
English: • Do not use Infanrix Penta after the expiry date which is stated on the carton.
Maltese: • Tużax Infanrix Penta wara d-data ta' skadenza li tidher fuq il-kartuna.
English: • Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination;
Maltese: • Kollass jew stat f'dehra ta' xokk (episodju ipotoniku-iporesponsiv) fi żmien 48 siegħa mittilqima.
English: 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4)
Maltese: 3adsorbit fuq aluminium phosphate (AlPO4 )
English: Infanrix Penta Suspension for injection DTPa-HBV-IPV IM
Maltese: DTPa-HBV-IPV
English: In the event of either being observed, discard the container.
Maltese: Wara li l-marda tiġi kkontrollata, it-tilqima tista' tingħata.
English: Thrombocytopenia has been reported with hepatitis B vaccine.
Maltese: Ġiet irrappurtata tromboċitopenja bil-vaċċin ta' l-epatite B.
English: Димитър Манов бл.10
Maltese: B'10 LABRIET 20
English: • temporarily stopping breathing (apnoea)
Maltese: • waqfien temporanju ta' teħid tan-nifs (apnea)
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stoppers (butyl).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.5mL ta' suspensjoni ġo siringa mimlija lesta (ħġieġ tip I) b'tappijiet għal-plunger (butyl).
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml) 20 pre-filled syringes + 20 needles 20 x 1 dose (0.5 ml)
Maltese: 20 siringi mimlijin lesti + 20 labra 20 x 1 doża (0.5 ml)
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline A.E.B.E.
English: • Make sure your child finishes the complete vaccination course.
Maltese: • Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall-skop kummerċjali.
English: GlaxoSmithKline ehf.
Maltese: GlaxoSmithKline AB
English: Antibody levels were not different from what was observed in a parallel cohort administered 4 doses of monovalent hepatitis B vaccine.
Maltese: Il-livelli ta'antikorpi ma kienux differenti minn dak li kien osservat f'ko-ort paralleli li ingħata 4 dożi tal-vaċċin
English: България
Maltese: Ireland
English: - a NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule).
Maltese: - Studju dwar l-effikaċja, sponsorjat mill-NIH li sar ġewwa l-Italja (skeda ta' 2,4,6 xhur).
English: 4.5 Interaction with other medicinal products and other forms of interaction Clinical studies have demonstrated that Infanrix Penta can be administered simultaneously with Haemophilus influenzae type b vaccines.
Maltese: Studji kliniċi wrew li Infanrix Penta tista tingħata flimkien mal-vaċċini ta' kontra l-Haemophilus influenzae tip b.
English: There is no relevant use of Infanrix Penta in children over 36 months.
Maltese: M'hemmx użu rilevanti għal Infanrix Penta fi tfal li għandhom aktar minn 36 xahar.
English: 50 x 1 dose (0.5 ml) 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Maltese: 1 siringa mimlija lesta + 1 labra 1 doża (0.5 ml)
English: 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Maltese: MINGĦAJR LABAR 20 SIRINGA MIMLIJIN LESTI
English: • a sudden drop in blood pressure and loss of consciousness.
Maltese: • il-pressjoni taqa' f'daqqa waħda u tintilef minn sensik.
English: Booster vaccination during the second year of life following a three dose primary course N = 350
Maltese: Vaċċinazzjoni booster matul it-tieni sena ta' ħajja wara kors primarju ta' tlett dożi N = 350
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Maltese: • fi trabi li jitwieldu ħafna qabel iż-żmien (fit-28 ġimgħa ta' ġestazzjoni jew qabel) jista' jkun hemm perjodi itwal minn normal bejn nifs u ieħor għal 2-3 ijiem wara t-tilqima
English: Tel: + 421 (0)2 48 26 11 11
Maltese: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: Infanrix Penta is a turbid white suspension.
Maltese: Infanrix Penta hija suspensjoni, bajda u mdardra.
English: Important information about some of the ingredients of Infanrix Penta This vaccine contains neomycin and polymyxin (antibiotics).
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Infanrix Penta Dan il-vaċċin fih neomycin u polymyxin (antibijotiċi).
English: Collapse or shock-like state (hypotonic-hyporesponsiveness episode) Respiratory, thoracic and mediastinal disorders:
Maltese: Disturbi fis-sistema nervuża Kollass jew stat bħal ta' xokk (episodju ta' hypotonic-hyporesponsiveness)
English: Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Maltese: Infanrix Penta hija indikata għat-tilqim primarju u tilqim booster ta' tfal żgħar kontra d-difterite, tetnu, sogħla konvulsiva, epatite B u poljomelite.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA' LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: • Clinical trials
Maltese: TAL-PRODOTT MEDIĊINALI
English: Κύπρος
Maltese: MANIFATTURI
English: • fits - this may be when they have a fever These side effects have happened very rarely with other vaccines against whooping cough.
Maltese: Dawn l-effetti sekondarji ġraw b'mod rari ħafna b'tilqim ieħor kontra s-sogħla konvulsiva.
English: 50 pre-filled syringes
Maltese: LABRA 50
English: Very rare: convulsions (with or without fever) Respiratory, thoracic and mediastinal disorders
Maltese: Rari ħafna: aċċessjonijiet (bi jew mingħajr deni) Disturbi respiratorji, toraċiċi u medjastinali
English: After a vaccination with 2 doses (e.g. 3, 5 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age.
Maltese: Wara tilqima b'żewġ dożi (e.ż. 3, 5 xhur) ta' Infanrix Penta għandha tingħata doża booster almenu 6 xhur wara l-aħħar doża primarja, preferibbilment bejn l-eta' ta' 11 u 13-il-xahar.
English: It makes the liver swollen.
Maltese: Kif tingħata t-tilqima
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.06 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni 3.06 inkluża f' Modulu 1.8.1 tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fuq is-suq
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Maltese: Rari ħafna (dawn jistgħu jiġru b'mhux aktar minn doża 1 minn kull 10,000 doża tat-tilqima)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 20 PRE-FILLED SYRINGES WITH 20 NEEDLES 50 PRE-FILLED SYRINGES WITH 50 NEEDLES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA 1 SIRINGA MIMLIJA LESTA MINGĦAJR LABBRA 10 SIRINGI MIMLIJIN LESTI
English: ND = not determined * in a subgroup of infants not administered hepatitis B vaccine at birth, 80.2% of subjects had antiHBs titres ≥ 10 mIU/ml † cut-off accepted as indicative of protection
Maltese: * f'subgrupp ta' trabi li ma ngħatawx il-vaċċin ta' l-epatite B fit-twelid, 80.
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Maltese: Is-suspensjoni tad-Difterite, tetnu, pertussis aċellulari, epatite B, poljomijelite inattivata (DTPa-HBVIPV) għandha tiġi spezzjonata viżwalment biex wieħed jara jekk hemmx xi frak u/jew xi dehra fiżika mhux normali.
English: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00
Maltese: GlaxoSmithKline, S.A. Tel: + 34 902 202 700
English: Italia
Maltese: España
English: - a high temperature (over 40°C) within 48 hours of vaccination - a collapse or ‘shock-like' state within 48 hours of vaccination - persistent crying lasting 3 hours or more within 48 hours of vaccination - fits with or without a high temperature within 3 days of vaccination
Maltese: • wara li fil-passat ħadu Infanrix Penta jew xi tilqim ieħor kontra s-sogħla konvulsiva, ibnek/bintek kellhom xi problemi, speċjalment: - deni għoli ('l fuq minn 40° C) fi żmien 48 siegħa mit-tilqima - kollass jew stat qisu ta' xokk fi żmien 48 siegħa mit-tilqima - biki persistenti li jdum tlett sigħat jew aktar fi żmien 48 siegħa mit-tilqima - aċċessjonijiet b`deni għoli jew mingħajru fi żmien 3 ijiem mit-tilqima
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali ta' waqfien tan-nifs għal xi ħin u l-bżonn ta' monitoraġġ respiratorju għal 48-72 siegħa, għandhom jiġu kkunsidrati meta l-kors ta' tilqim primarju jingħata lit-trabi mwieldin ħafna qabel iż-żmien (twieldu ≤ 28 ġimgħa ta' tqala) u speċjalment f'dawk li diġà kellhom immaturità
English: • Infanrix Penta will be given as an injection into a muscle.
Maltese: • Infanrix Penta jingħata bħala injezzjoni ġol-muskolu.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: F'kull grupp ta' frekwenza, effetti mhux mixtieqa jidhru f'ordni ta' tnaqqis fis-serjetà tal-każ.
English: Swelling of the entire injected limb*
Maltese: Suspensjoni għall-injezzjoni
English: * Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
Maltese: • Bħal b'kull tilqim ieħor, Infanrix Penta jista' ma jipproteġix kompletament lit-tfal kollha li jitlaqqmu.
English: • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
Maltese: • Biki kontinwu ta ≥ 3 sigħat, fi żmien 48 siegħa mit-tilqima.
English: Infanrix Penta should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Maltese: Bħal fil-każ ta' vaċċini oħra, wieħed jista' jistenna li f'pazjenti li qiegħdin fuq terapija immunosoppressiva, jista' ma jinkisibx riżultat sodisfaċenti.
English: The full EPAR for Memantine ratiopharm 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: Memantine ratiopharm is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Maltese: Memantine ratiopharm jiġi f'pilloli (5 mg, 10 mg, 15 mg u 20 mg) u jinkiseb biss b'riċetta ta' tabib.
English: The active substance in Memantine ratiopharm, memantine hydrochloride, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Memantine ratiopharm, il-memantina kloridrat, hija mediċina kontra d-demenzja.
English: It is used to treat patients with moderate to severe Alzheimer's disease.
Maltese: Dan jintuża għattrattament ta' pazjenti bil-marda ta' Alzheimer moderata sa gravi.
English: This is a summary of the European public assessment report (EPAR) for Memantine ratiopharm.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Memantine ratiopharm.
English: Memantine ratiopharm memantine hydrochloride
Maltese: Aktar tagħrif dwar Memantine ratiopharm
English: Memantine ratiopharm is a medicine that contains the active substance memantine hydrochloride.
Maltese: Memantine ratiopharm huwa mediċina li fih is-sustanza attiva memantina kloridrat.
English: To prevent side effects, the dose of Memantine ratiopharm is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Biex jiġu evitati effetti sekondarji, id-doża ta' Memantine ratiopharm għandha tiżdied b'mod gradwali matul l-ewwel tliet ġimgħat tattrattament: fl-ewwel ġimgħa d-doża tkun 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fit-tielet ġimgħa ssir 15 mg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine ratiopharm on 13 June 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Memantine ratiopharm fit-13 ta' Ġunju 2013.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine ratiopharm has been shown to have comparable quality and to be bioequivalent to Ebixa.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Memantine ratiopharm għandu kwalità komparabbli u huwa bijoekwivalenti għal Ebixa.
English: This means that Memantine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Maltese: Memantine ratiopharm huwa ‘mediċina ġenerika' Dan ifisser li Memantine ratiopharm huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Ebixa.
English: Why is Memantine ratiopharm approved?
Maltese: Għaliex ġie approvat Memantine ratiopharm?
English: Because Memantine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Memantine ratiopharm huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, tqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Memantine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Maltese: Peress li Memantine ratiopharm huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Ebixa.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku memantina idroklorika
English: Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Il-marda ta' Alzheimer hija tip ta' demenzja (diżordni fil-moħħ) li bil-mod il-mod taffettwa l-memorja, il-kapaċità intellettwali u l-imġiba.
English: Other information about Memantine ratiopharm
Maltese: Kif jintuża Memantine ratiopharm?
English: How has Memantine ratiopharm been studied?
Maltese: Kif ġie studjat Memantine ratiopharm?
English: What are the benefits and risks of Memantine ratiopharm?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Memantine ratiopharm?
English: Memantine ratiopharm is a ‘generic medicine'.
Maltese: X'inhu Memantine ratiopharm u għalxiex jintuża?
English: EMA/121929/2017 EMEA/V/C/003939
Maltese: EMEA/121929/2017 EMEA/V/C/003939
English: The full EPAR for Cytopoint can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.