FrancophonIA/ELRC3.0 huggingface dataset:
English: At one year, 83.5 % (p= 0.006) of patients receiving Bonviva 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50 % from baseline).
Maltese: Mal-ewwel sena, 83.5 % (p= 0.006) tal-pazjenti li kienu qed jirċievu Bonviva 150 mg darba fix-xahar u 73.9 % tal-pazjenti li kienu qed jirċievu ibandronic acid 2.5 mg kuljum kienu identifikati bħala dawk li rrispondew (definit bħala tnaqqis ta' ≥50 % mil-linja bażi).
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Maltese: Każijiet ta' reazzjoni/xokk anafilattiku, inklużi avvenimenti fatali, kienu rrappurati f'pazjenti kkurati b'ibandronic acid fil-vina.
English: Due to the limited clinical experience, Bonviva is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Maltese: Minħabba li lesperjenza klinika hija limitata, Bonviva mhux rakkomandat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 4.2 u sezzjoni 4.4).
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bonviva is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Maltese: Minħabba l-possibbiltà ta' dawn l-effetti irritanti u l-potenzjal ta' rkadar talmarda prinċipali, għandu jkun hemm kawtela meta Bonviva jingħata lill-pazjenti bi problemi attivi talapparat gastro-intestinali ta' fuq li jkunu magħrufa (eż. esofagu ta' Barrett, disfaġija, mard esofagali ieħor, gastrite, duwodenite jew ulċeri).
English: Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5),
Maltese: Il-pazjenti għandhom jirċievu kalċju u/jew vitamina D supplimentari (ara sezzjoni 4.4 u sezzjoni 4.5).
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Maltese: It-tneħħija totali ta' ibandronic acid hija baxxa b'valuri medji fl-iskala ta' 84-160 ml/min.
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, ocular inflammation, (see paragraph “Description of selected adverse reactions” and section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji rrappurtati huma reazzjoni anafilattika/xokk, ksur mhux tipiku talgħadma tal-wirk, osteonekrosi tax-xedaq, irritazzjoni gastrointestinali, infjammazzjoni fl-għajnejn, (ara l-paragrafu “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4).
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis (see section 4.8).
Maltese: Osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) kienet irrappurtata b'mod rari ħafna flambjent ta' wara t-tqegħid fis-suq f'pazjenti li jirċievu Bonviva għall-osteoporożi (ara sezzjoni 4.8).
English: Bioavailability is reduced by about 90 % when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Maltese: Il-bijodisponibiltà tonqos b'madwar 90% meta ibandronic acid jingħata ma' kolazzjon stàndard meta mqabbla ma' bijodisponibiltà osservata f'individwi sajmin.
English: In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity.
Maltese: F'voluntiera maskili b'saħħithom u f'nisa wara l-menopawsa, l-għoti ta' ranitidine minn ġol-vina kkawża żjieda ta' madwar 20% fil-bijodisponibiltà ta' ibandronic acid, probabbilment bħala riżultat ta' tnaqqis tal-aċidità gastrika.
English: NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets Ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bonviva 150 mg pilloli miksija b'rita Ibandronic acid
English: • If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
Maltese: • Jekk għandek xi disturbi fil-metaboliżmu tal-minerali (bħal defiċjenza ta' vitamina D).
English: *See further information below †Identified in post-marketing experience.
Maltese: *Ara taħt għal aktar informazzjoni †Identifikati minn esperjenza ta' wara t-tqegħid fis-suq.
English: Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).
Maltese: Bonviva mhux irrakkomandat għal pazjenti bi tneħħija tal-krejatinina taħt 30 ml/min minħabba esperjenza klinika limitata (ara sezzjoni 4.4 u sezzjoni 5.2).
English: ibandronic acid 2.5 mg daily (N=318)
Maltese: ibandronic acid 2.5 mg kuljum (N=318)
English: Continuing to take Bonviva
Maltese: Tiħux Bonviva
English: Bonviva 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Maltese: Bonviva 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest għandha tiġi injettata ġol-vina fuq perjodu ta' 15 - 30 sekonda.
English: Due to limited clinical experience, Bonviva injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Maltese: Minħabba esperjenza klinika limitata, injezzjoni ta' Bonviva mhix irrakkomandata għal pazjenti bi krejatinina fis-serum 'il fuq minn 200 μmol/l (2.3 mg/dl) jew bi tneħħija tal-krejatinina taħt 30 ml/min (ara sezzjoni 4.2 u sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection Ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bonviva 3 mg soluzzjoni għall-injezzjoni Ibandronic acid
English: Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures.
Maltese: Fatturi ta' riskju indipendenti, per eżempju, BMD baxx, età, l-eżistenza ta' ksur minn qabel, passat ta' ksur fil-familja, bidla għolja fl-għadam u indiċi tal-massa tal-ġisem baxx għandhom jiġu kkunsidrati sabiex jiġu identifikati nisa f'riskju akbar ta' ksur osteoporotiku.
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women.
Maltese: Sess Il-bijodisponibiltà u l-farmakokinetika ta' ibandronic acid huma simili fl-irġiel u fin-nisa.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Maltese: M'hemmx tnaqqis sinifikanti fil-bijodisponibiltà jekk ibandronic acid jittieħed 60 minuta qabel l-ewwel ikel tal-ġurnata.
English: Calcium supplements, antacids and some oral medicinal products containing multivalent cations Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bonviva.
Maltese: Supplimenti tal-kalċju, antaċidi u xi prodotti mediċinali li jittieħdu mill-ħalq li fihom ketajins multivalenti (bħall-aluminju, l-magneżju u l-ħadid) x'aktarx li jinterferixxu mal-assorbiment ta' Bonviva.
English: Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Maltese: Ibandronic acid iwassal għal żidiet progressivi netti fil-massa tal-għadam u għal inċidenza mnaqqsa ta' ksur billi jnaqqas it-tibdil elevat tal-għadam lejn livelli ta' qabel ilmenopawsa f'nisa wara l-menopawsa.
English: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Maltese: Marda li tixbah lill-influwenza tinkludi avvenimenti rrappurtati bħala reazzjoni jew sintomi ta' fażi akuta inkluż mijalġja, artralġja, deni, tertir, għeja, tqalligħ, nuqqas ta' aptit, u wġigħ fl-għadam.
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50 % in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Maltese: Il-frazzjoni ta' ibandronic acid assorbita titneħħa miċ-ċirkolazzjoni permezz ta' assorbiment fl-għadam (stmat li huwa 40-50% f'nisa wara l-menopawsa) u l-bqija jiġi eliminat mingħajr ma jinbidel millkliewi.
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bonviva 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Maltese: Għal BMD totali tal-ġenbejn, 90.0 % (p<0.001) tal-pazjenti li kienu qed jirċievu Bonviva 150 mg darba fix-xahar u 76.7 % tal-pazjenti li kienu qed jirċievu ibandronic acid 2.5 mg kuljum kellhom żieda fil-BMD totali tal-ġenbejn 'il fuq jew daqs il-linja bażi mal-ewwel sena.
English: At two years the median relative change was -68 % and -62 %, in the 150 mg monthly and 2.5 mg daily arms respectively.
Maltese: Mattieni sena l-bidla medjana relattiva kienet -68 % u -62 %, fil-gruppi ta' 150 mg kull xahar u 2.5 mg kuljum rispettivament.
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Maltese: Mat-tieni sena, 87.1 % (p<0.001) u 70.5 %, tal-pazjenti laħqu dan il-kriterju fil-gruppi ta' 150 mg kull xahar u 2.5 mg kuljum rispettivament.
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6 %.
Maltese: Ilkonċentrazzjonijiet massimi osservati fil-plażma ntlaħqu fi żmien 0.5 sa 2 sigħat (medjan ta' siegħa) fi stat sajjem u l-bijodisponibiltà assoluta kienet madwar 0.6%.
English: Back pain Atypical subtrochanteric and diaphyseal femoral fractures†
Maltese: Ksur subtrochanteric u diaphyseal mhux tipiku talgħadma tal-wirk
English: One year data in study BM 16550 Two year data in study BM 16550
Maltese: Tagħrif kumulattiv ta' wara sentejn fl-istudju BM 16550
English: Bonviva 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Maltese: Bonviva 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bħal bisphosphonates oħra mogħtija ġol-vina, jista' jikkawża tnaqqis temporanju fil-valuri ta' kalċju fis-serum.
English: ibandronic acid 2.5 mg daily (N=977)
Maltese: ibandronic acid 2.5 mg kuljum (N=977)
English: There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population (see section 5.1 and 5.2).
Maltese: M'hemm l-ebda użu rilevanti fi tfal ta' età inqas minn 18-il sena, u Bonviva ma kienx studjat f'din ilpopolazzjoni (ara sezzjoni 5.1 u sezzjoni 5.2).
English: Due to limited clinical experience, Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Maltese: Minħabba esperjenza klinika limitata, Bonviva mhux irrakkomandat għal pazjenti bi tneħħija talkrejatinina taħt 30 ml/min (ara sezzjoni 5.2).
English: Bonviva 3 mg injection every 3 months
Maltese: Injezzjoni ta' Bonviva 3 mg kull 3 xhur
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Maltese: Barra dan, ibandronic acid ma jinibixxix liżoenzimi P450 maġġuri umani tal-fwied u ma jinduċix is-sistema taċ-ċitokromju P450 tal-fwied filfirien.
English: • if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)
Maltese: • jekk inti allerġiku għal ibandronic acid, jew għal xi sustanza oħra din il-mediċina (elenkati fissezzjoni 6).
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bonviva.
Maltese: Jekk qed tirċievi trattament dentali jew ser tagħmel kirurġija dentali (eż. qlugħ ta' snien), għarraf littabib tiegħek dwar it-trattament dentali tiegħek u għid lid-dentist tiegħek li qed tiġi ttrattat b'Bonviva.
English: The tablets are supplied in blisters containing 1 or 3 tablets.
Maltese: Il-pilloli huma disponibbli f'folji li fihom pillola waħda jew 3 pilloli.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bonviva in patients with concomitant risk factors.
Maltese: Eżami dentali b'dentistrija preventiva u stima tal-benefiċċju u r-riskju individwali huma rakkomandati qabel trattament b'Bonviva f'pazjenti b'fatturi ta' riskju konkomitanti.
English: How to store Bonviva
Maltese: Kompli rċievi Bonviva
English: NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Bonviva 3 mg soluzzjoni għall-injezzjoni
English: Pre-filled syringes (5 ml) made of colourless type I glass, the grey rubber plunger stopper and tip cap are made of fluororesin-laminated butyl rubber, containing 3 ml of solution for injection.
Maltese: Siringi mimlija għal-lest (5 ml) li fihom 3 ml ta' soluzzjoni għall-injezzjoni, magħmula minn ħġieġ bla kulur tat-Tip I, it-tapp tal-planġer griż tal-lasktu u l-għatu tat-tarf huma magħmula minn lastku llaminat bi fluororesin.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Maltese: Listudju involva nisa ta' età minn 55 sa 80 sena, li kienu mill-inqas 5 snin wara l-menopawsa u li kellhom BMD fis-sinsla lumbari ta' -2 sa -5
English: One year data in study BM 16549 Two year data in study BM 16549
Maltese: Tagħrif kumulattiv ta' wara sentejn fl-istudju BM 16549
English: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Maltese: Kura tal-osteoporożi fin-nisa f'riskju akbar ta' ksur wara l-menopawsa (ara sezzjoni 5.1).
English: • severe adverse skin reactions
Maltese: • reazzjoni allerġika serja li tista' tkun fatali
English: • bone pain
Maltese: X'fih Bonviva
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: • persistent eye pain and inflammation
Maltese: • uġigħ persistenti fl-għajn u infjammazzjoni
English: Angioedema, Face oedema, Urticaria
Maltese: Gastrite, Dispepsja, Dijarea, Uġigħ addominali, Tqalligħ, Stitikezza
English: Where Bonviva is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Maltese: Fejn Bonviva jingħata minn ġo pajp tal-infużjoni ġol-vina eżistenti, l-infusat għal ġol-vina għandu jiġi ristrett għal isotonic saline jew soluzzjoni ta' 50 mg/ml (5 %) ta' glukosju.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Maltese: Fost dawn ilpazjenti, l-inċidenza ta' avvenimenti gastro-intestinali ta' fuq fil-pazjenti kkurati b'Bonviva 150 mg darba fix-xahar kienet simili għal dik f'pazjenti kkurati b'ibandronic acid 2.5 mg kuljum.
English: Bonviva 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Maltese: Barra minn hekk, f'analiżi prospettiva ppjanata mal-ewwel sena, p=0.002, u mas-sentejn, p<0.001, ġie ppruvat li Bonviva 150 mg darba fix-xahar kien superjuri għal ibandronic acid 2.5 mg kuljum biex iżid il-BMD tas-sinsla lumbari.
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Maltese: • Poġġi l-labar u s-siringi użati kollha f'kontenitur għall-oġġetti li jaqtgħu (kontenitur li jintrema u li ma jittaqqabx).
English: Table 1: Adverse reactions occurring in postmenopausal women receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM16549 and MF4411 and in postmarketing experience.
Maltese: Tabella 1: Reazzjonijiet avversi li seħħew f'nisa wara l-menopawsa li kienu qed jirċievu Bonviva 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum fl-istudji ta' fażi
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05-BA06
Maltese: Qabel tirċievi it-trattament, għid lit-tabib/infermier (professjonist fil-kura tas-saħħa) tiegħek jekk:
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Maltese: Meta jkun ikkunsidrat kriterju aktar strett, li jikkombina kemm il-BMD tas-sinsla lumbari kif ukoll ilBMD totali tal-ġenbejn, 83.9 % (p<0.001) u 65.7 % tal-pazjenti li kienu qed jirċievu Bonviva 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum, rispettivament, kienu dawk li rrispondew malewwel sena.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Maltese: L-assorbiment ta' ibandronic acid fil-parti ta' fuq tas-sistema gastro-intestinali seħħ malajr wara għoti mill-ħalq u l-konċentrazzjonijiet fil-plażma jiżdiedu proporzjonalment mad-doża sa 50 mg ta' teħid orali, b'żjiediet akbar milli proporzjonalment mad-doża osservati 'l fuq minn din id-doża.
English: Bonviva 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products.
Maltese: Bonviva 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest m'għandux jitħallat ma' soluzzjonijet li fihom il-kalċju (bħal soluzzjoni Ringer-Lactate, calcium heparin) jew prodotti mediċinali oħra li jingħataw ġol-vina.
English: Based on the results of study BM 16550, Bonviva 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Maltese: Ibbażat fuq ir-riżultati tal-istudju BM 16550, Bonviva 3 mg injezzjoni ġol-vina darba kull 3 xhur huwa mistenni li tkun minn tal-inqas effettiva daqs ibandronic acid 2.5 mg kuljum biex tippreveni l-ksur.
English: NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Bonviva 150 mg pilloli miksija b'rita.
English: Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity.
Maltese: Mudelli tal-annimali jikkonfermaw li ibandronic acid huwa inibitur qawwi ħafna tal-attività osteoklastika.
English: This medicinal product contains lactose.
Maltese: Il-pilloli fihom ukoll lactose.
English: Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Maltese: Ipokalċimja u disturbi oħra tal-metaboliżmu tal-għadam u tal-minerali għandhom jiġu stmati u kkurati b'mod effettiv qabel tinbeda terapija ta' injezzjoni b'Bonviva.
English: After swallowing your monthly Bonviva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Maltese: Wara li tibla l-pillola tiegħek ta' kull xahar ta' Bonviva, stenna għal siegħa qabel tieħu xi mediċina oħra, inkluż pilloli għall-indiġestjoni, supplimenti ta' kalċju, jew vitamini.
English: The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Maltese: Id-differenza bejn it-tneħħija totali apparenti u ttneħħija mill-kliewi hija kkunsidrata li tirrifletti t-teħid mill-għadam.
English: Strict adherence to the intravenous administration route is required (see section 4.4).
Maltese: Huwa meħtieġ li r-rotta ta' għoti fil-vina tiġi segwita b'mod strett (ara sezzjoni 4.4).
English: 50 ml (25 doses)
Maltese: 50 ml (25 doża)
English: Sodium chloride solution (0.9%)
Maltese: Soluzzjoni tas-sodium chloride ( 0.9%) 6.2 Inkompatibilitajiet
English: Store in a refrigerator (2 ºC − 8 ºC).
Maltese: Aħżen fil-friġġ (2°C - 8°C).
English: 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Maltese: 1GMNU = Geometric mean of neutralizing units immunizzazzjoni indotta fil-fenek ta' l-indi wara ttieni tilqima ta' 0.5 ml b' dan il-vaċċin.
English: Excipient: Thiomersal
Maltese: Tiomersal
English: PET vials:
Maltese: Kunjetti PET:
English: For intramuscular use.
Maltese: Mhux Applikabbli.
English: 0.21 mg For the full list of excipients, see section 6.1.
Maltese: 0.21 mg Għal-lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: 20 ml Polyethylene terephthalate (PET) vials, clear 50 ml PET vials, clear
Maltese: Kunjetti tal-polyethylene terephthalate (PET) ta' 20 ml, trasparenti Kunjetti PET ta' 50 ml, trasparenti Kunjetti PET ta' 100 ml, trasparenti
English: Major incompatibilities
Maltese: Inkompatibilitajiet:
English: Carbomer 971 P NF Thiomersal
Maltese: 6.1 Lista ta' ingredjenti Carbomer 971 P NF Tiomersal
English: 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 8 x 500 ml (250 doses)
Maltese: 20 ml (10 dożi), 50 ml (25 doża), 100 ml (50 doża)
English: Pharmacotherapeutic group: Immunologicals, Inactivated viral vaccines ATCvet code: QI09AA03
Maltese: Immunologiċi, vaċċini li fihom virusijiet inattivati Kodici ATĊ veterinarja:
English: Adjuvant:
Maltese: Drafeġ:
English: (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
Maltese: 22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
English: DATE OF FIRST AUTHORISATION Date of first authorisation: 14/01/2010 Date of last renewal: 04/12/2014
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 14/01/2010
English: Name and address of the manufacturers of the biological active substances
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Respiporc FLU3 suspension for injection for pigs
Maltese: VETERINARJU RESPIPORC FLU3 suspensjoni għall-injezzjoni għall-ħnieżer.
English: The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Maltese: It-tilqima tqanqal immunità attiva kontra s-sottotipi H1N1, H3N2 u H1N2 tal-virus tal-Influwenza A
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Strains of inactivated Influenza A virus/swine
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Strejns tal-virus inattivat ta' l-influwenza A/ ħnieżer
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.