FrancophonIA/ELRC3.0 huggingface dataset:
English: - In another referral for an enrofloxacin oral solution (Hipralona Enro-S (EMEA/V/A/79))3 the Committee concluded that the risk is likely to be minor, in rabbits, in comparison with the other species due to the size of rabbit's production and no measures have been deemed necessary to minimize the risk for spread of methicillin resistant Staphylococcus aureus (MRSA) from those.
Maltese: - F'riferiment ieħor għal soluzzjoni orali ta' enrofloxacin (Hipralona Enro-S (EMEA/V/A/79))3 il-Kumitat ikkonkluda li r-riskju x'aktarx ikun minuri, fil-fniek, meta mqabbel mal-ispeċijiet l-oħrajn minħabba d-daqs tal-produzzjoni tal-fniek u ma tqieset meħtieġa l-ebda miżura biex timminimizza r-riskju ta' tixrid ta' Staphylococcus aureus li huwa reżistenti għallmetiċillina (MRSA) minn dawk.
English: - Dosage: 5 mg/kg bw, once daily for two consecutive days
Maltese: - Dożaġġ: 5 mg/kg bw, darba kuljum għal jumejn konsekuttivi
English: Therefore for the justification of the posology, a PK/PD were taken into account.
Maltese: Għalhekk għall-ġustifikazzjoni tal-pożoloġija, tqieset analiżi PK/PD.
English: The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Maltese: Din tal-aħħar tapplika wkoll għal infezzjonijiet fl-apparat alimentari u settiċemija kkawżati minn E. coli fil-majjali.
English: Enrofloxacin 100 mg.
Maltese: 1 ml ta' soluzzjoni fih: Enrofloxacin 100 mg.
English: Supporting literature for use of enrofloxacin was provided in rodents (e.g. hamsters, gerbils, guinea pigs), in reptiles (snakes, lizards and chelonia) and in ornamental birds.
Maltese: Ġiet ipprovduta letteratura għall-użu ta' enrofloxacin fir-rodituri (pereżempju l-ħamsters, il-ġerbilli, il-fniek tal-Indi), fir-rettili (is-sriep, il-gremxul u l-chelonia) u fl-għasafar ornamentali.
English: Dose rate (mg/kg bw) Route of administration im im iv sc
Maltese: Rata ta' doża (mg/kg bw)
English: Bayer Hispania S.L.
Maltese: Is-Slovakkja BAYER s.r.o.
English: Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))
Maltese: Klieb, qtates, u speċijiet eżotiċi oħra (rodituri, fniek, għasafar tal-gaġġa u rettili (sriep, fkieren u iguana))
English: Similarly, for Mycoplasma spp.
Maltese: Mycoplasma bovis.
English: Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice.
Maltese: Kura ta' infezzjonijiet fil-passaġġ alimentari u respiratorju fejn l-esperjenza klinika, jekk ikun possibbli, appoġġjata minn ittestjar tas-suxxettibilità tal-organiżmu kawżali, tindika enrofloxacin bħala s-sustanza ta' għażla.
English: In countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure (see Commission Decision 2003/322/EC), the possible risk to hatching success should be considered before feeding carcasses of livestock recently treated with this product.
Maltese: Prekawzjonijiet oħra Fil-pajjiżi fejn huwa permess it-tmigħ ta' annimali mejta lil popolazzjonijiet ta' għasafar li jieklu annimali mejta bħala miżura ta' konservazzjoni (ara d-Deċiżjoni tal-Kummissjoni 2003/322/KE), għandu jiġi kkunsidrat ir-riskju possibbli biex jirnexxi t-tfaqqis qabel it-tmigħ tal-karkassi tal-bhejjem li jkunu ġew reċentement ikkurati b'dan il-prodott.
English: Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.
Maltese: Għandha tingħata attenzjoni speċjali meta jintuża enrofloxacin fl-annimali b'indeboliment fil-funzjoni tal-fwied.
English: PK/PD and antimicrobial resistance data have been taken into account to justify this indication.
Maltese: Iddejta PK/PD u dwar ir-reżistenza antimikrobika tqieset biex tiġi ġġustifikata din l-indikazzjoni.
English: For cats weighting less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see Overdose).
Maltese: Għal qtates li jiżnu anqas minn 5 kg, id-dożaġġ ta' 25 mg/ml huwa aktar xieraq biex jiġi evitat ir-riskju ta' dożaġġ eċċessiv (ara Doża Eċċessiva).
English: - Dosage for reptiles: 5-10 mg/kg bw, once daily by intramuscular injection for 5 consecutive days.
Maltese: - Dożaġġ għar-rettili: 5-10 mg/kg bw, darba kuljum permezz ta' injezzjoni ġol-muskolu għal 5
English: TARGET SPECIES Dogs, cats, pigs (piglets), rabbits, rodents, reptiles and ornamental birds
Maltese: HUWA INDIKAT IL-PRODOTT Klieb, qtates, ħnieżer (qżieqeż), fniek, rodituri, rettili u għasafar ornamentali
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 25 mg/ml solution for injection Enrofloxacin
Maltese: <Isem ivvintat> 25 mg/ml soluzzjoni għall-injezzjoni Enrofloxacin
English: Cattle meat and offal (50 mg/ml and 100 mg/ml strengths) Residue depletion data were made available and supported a cattle meat and offal withdrawal period of 5 days following an intravenous injection at the recommended dose of 5 mg/kg bw.
Maltese: Laħam u ġewwieni tan-nagħaġ (qawwiet ta' 50 mg/ml u 100 mg/ml) Dejta dwar it-tnaqqis tar-residwi ġiet magħmula disponibbli u appoġġat perjodu ta' tiżmim ta' 4 ijiem għal-laħam u l-ġewwieni tan-nagħaġ wara injezzjoni taħt il-ġilda fid-doża rakkomandata ta' 5 mg/kg tal-piż tal-ġisem.
English: Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg of bw, corresponding to 2 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Maltese: Mastite akuta kkawżata minn Escherichia coli: 5 mg enrofloxacin/kg bw, li tikkorrispondi għal
English: The CVMP position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03)1 establishes that cattle (dairy and meat animals) and sheep (meat animals) are considered as major food-producing species.
Maltese: Id-dokument ta' pożizzjoni tas-CVMP fir-rigward tad-disponibbiltà ta' prodotti għal użi minuri u speċijiet minuri (EMEA/CVMP/477/03)1 jistabbilixxi li l-annimali tal-ifrat (annimali tal-ħalib u tallaħam) u n-nagħaġ (annimali tal-laħam) jitqiesu bħala speċijiet ewlenin għall-produzzjoni tal-ikel.
English: Pigs (25 mg/ml, 50 mg/ml and 100 mg/ml strengths) Residue depletion data were made available and supported a pig meat and offal withdrawal period of 13 days following an intramuscular administration at the recommended dose of 5 mg/kg bw.
Maltese: Laħam u ġewwieni tal-mogħoż (qawwiet ta' 50 mg/ml u 100 mg/ml) Ma kien hemm l-ebda dejta disponibbli dwar it-tnaqqis tar-residwi.
English: Therefore the CVMP considered that these indications can be accepted for dogs and cats, when taking into account that the PK/PD data shown are theoretically predictive of good clinical efficacy in the treatment of the bacterial infections for which the products are intended, and the efficacy of the products has been confirmed by field studies and good clinical experience since more than two decades.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Maltese: 2.5 mg ta' enrofloxacin/kg bw, li tikkorrispondi għal 1 ml/10 kg bw, darba kuljum permezz ta'
English: Cattle 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Maltese: 5 mg ta' enrofloxacin/kg bw, li tikkorrispondi għal 1 ml/20 kg bw, darba kuljum għal 3-5 ijiem.
English: Calves, pigs, poultry, dogs, cats
Maltese: Klieb, qtates, annimali talifrat , tjur, ħnieżer
English: The data provided are insufficient to justify two indications in cattle (i) ‘treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Histophilus somni' and (ii) ‘treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus'.
Maltese: Id-dejta pprovduta mhijiex biżżejjed biex tiġġustifika żewġ indikazzjonijiet fil-frat (i) ‘kura ta' infezzjonijiet fil-passaġġ respiratorju ikkawżati minn razez ta' Histophilus somni suxxettibbli għal enrofloxacin' u (ii) ‘kura ta' mastite severa akuta ikkawżata minn razez ta' Staphylococcus aureus suxxettibbli għal enrofloxacin'.
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of: Pasteurella multocida, Mycoplasma spp., Actinobacillus pleuropneumoniae.
Maltese: Pasteurella multocida, Mycoplasma spp., uActinobacillus pleuropneumoniae.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 50 mg/ml solution for injection Enrofloxacin
Maltese: <Isem ivvintat> 50 mg/ml soluzzjoni għall-injezzjoni Enrofloxacin
English: Treatment of skin and wound infections caused by enrofloxacin susceptible strains of: Staphylococcus aureus.
Maltese: Il-kura ta' infezzjonijiet tal-ġilda u l-feriti kkawżati minn razez suxxettibbli għal enrofloxacin ta: Staphylococcus aureus.
English: SC: Meat and offal: 10 days.
Maltese: Laħam u interjuri: 10 ijem.
English: Use in pregnancy and lactation
Maltese: ANNESS I KARATTERISTIĊI
English: • the CVMP considered the scope of the referral was the harmonisation of the summaries of product characteristics, labelling and package leaflets;
Maltese: • is-CVMP qies li l-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tas-sommarji tal karatteristiċi tal-prodott, it-tikkettar u l-fuljetti ta' tagħrif;
English: Although the scientific justification for this indication is not as robust as desirable, a clinical cure (response to treatment) of 87.5% was obtained in infections involving Staph.
Maltese: Għalkemm il-ġustifikazzjoni xjentifika għal din l-indikazzjoni mhijiex soda daqs kemm mixtieqa, inkisbet kura klinika (reazzjoni għall-kura) ta' 87.5% fl-infezzjonijiet li jinvolvu
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 100 mg/ml solution for injection Enrofloxacin
Maltese: <Isem ivvintat> 100 mg/ml soluzzjoni għall-injezzjoni Enrofloxacin
English: Both strengths share the same indications, but differences exist in terms of target animal species i.e. in the 50 mg/ml strength the species were stated as dairy ewes/lambs and dairy goats/kids whereas in the 100 mg/ml strength the species were sheep and goats.
Maltese: Bħala konklużjoni, din l-indikazzjoni fil-ħnieżer nisa tista' tiġi aċċettata għall-qawwa ta' 100 mg/ml, iżda mhux għall-qawwa ta' 50 mg/ml, minħabba li l-għoti tal-prodott bil-qawwa iktar baxxa ma tistax tiġi pprattikata f'annimali tqal.
English: Enrofloxacin 25 mg.
Maltese: 1 ml ta' soluzzjoni fih: Enrofloxacin 25 mg.
English: Further information on Dany's BienenWohl can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Dany's BienenWohl tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The dispersion should be warmed to 30-35˚C before application.
Maltese: Iddispersjoni għandha tissaħħan għal 30-35˚C qabel tiġi applikata.
English: Three weeks of treatment Dany's BienenWohl led to the death of 97 and 95 % of the mites.
Maltese: Tliet ġimgħat ta' kura Dany's BienenWohl wasslu għall-mewt ta' 97 u 95% tad-dud.
English: Dany's BienenWohl received a marketing authorisation valid throughout the EU on 14 June 2018.
Maltese: Dany's BienenWohl ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 14/06/2018.
English: Other information about Dany's BienenWohl
Maltese: Informazzjoni oħra dwar Dany's BienenWohl
English: Up to 6 ml of Dany's BienenWohl are trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3˚C.
Maltese: Sa 6 ml ta' Dany's BienenWohl jitqattar fuq innaħal fid-doqqajs u għandu jintuża biss meta t-temperatura barra d-doqqajs tkun mill-inqas 3˚C.
English: Dany's BienenWohl contains the active substance oxalic acid.
Maltese: Dany's BienenWohl fih is-sustanza attiva aċidu ossaliku.
English: The effectiveness of Dany's BienenWohl against varroa mites was investigated in two field studies in European countries with different climates.
Maltese: L-effikaċja ta' Dany's BienenWohl kontra l-varro mites ġiet investigata f'żewġ studji fuq il-post fil-pajjiżi Ewropej bi klimi differenti.
English: The company that makes Oxybee has agreed that its scientific data can be used for Dany's BienenWohl (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Oxybee qablet li d-data xjentifika tiegħu tista' tintuża għal Dany's BienenWohl (“kunsens infurmat”).
English: The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees.
Maltese: Il-varroa mite tiekol mill-emolimfa (demm) tan-naħal adult u tad-duqqajs (listadji tal-iżvilupp tan-naħla tal-għasel) li jirriżulta fil-ħsara u/jew fil-mewt tan-naħal.
English: What are the risks associated with Dany's BienenWohl?
Maltese: X'inhuma r-riskji assoċjati ma' Dany's BienenWohl?
English: If possible, the use of Dany's BienenWohl should be alternated with another medicine that kills mites in a different way to reduce the chance of the mites developing resistance.
Maltese: Jekk ikun possibbli, l-użu ta' Dany's BienenWohl għandu jiġi alternat ma' mediċina oħra li toqtol id-dud b'mod differenti biex tnaqqas iċ-ċans li d-dud jiżviluppa reżistenza.
English: This authorisation was based on the authorisation granted to Oxybee in 2018 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Oxybee fl-2018 (“kunsens infurmat”).
English: Dany's BienenWohl is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose).
Maltese: Dany's BienenWohl huwa aċiduż ħafna u jista' jkun irritanti jew korrużiv għall-ġilda, l-għajnejn u lmembrani mukużi (is-saff ta' ġewwa tal-kavitajiet tal-ġisem bħall-ħalq u l-imnieħer).
English: Dany's BienenWohl is a medicine used to treat varroosis in honey bee colonies.
Maltese: Dany's BienenWohl huwa mediċina li tintuża għall-kura ta' varroażi f'kolonji tan-naħal tal-għasel.
English: Dany's BienenWohl is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Maltese: Dany's BienenWohl jiġi bħala trab u soluzzjoni għat-tħejjija ta' tixrid tad-doqqajs (likwidu biex jintuża fid-doqqajs) u jista' jinkiseb mingħajr riċetta tat-tabib.
English: How oxalic acid works on mites is not well understood but it is thought that the activity of oxalic acid on mites is due to the acidity of the medicine, which kills the mites on contact.
Maltese: Il-mod kif l-aċidu ossaliku jaħdem fuq id-dud mhuwiex mifhum sew iżda huwa maħsub li l-attività talaċidu ossaliku fuq id-dud hija dovuta għall-aċidità tal-mediċina, li toqtol id-dud mal-kuntatt.
English: Dany's BienenWohl can only be used on colonies without brood and should be used as part of a wider management programme.
Maltese: Dany's BienenWohl jista' jintuża biss fuq kolonji mingħajr duqqajs u għandu jintuża bħala parti minn programm ta' ġestjoni usa'.
English: In the first study treatment with Dany's BienenWohl was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Dany's BienenWohl was compared to a group with no treatment.
Maltese: Fl-ewwel studju, il-kura b'Dany's BienenWohl tqabblet ma' mediċina ta' aċidu ossaliku oħra u ma' grupp bl-ebda kura filwaqt li fit-tieni studju, il-kura b'Dany's BienenWohl tqabblet ma' grupp mingħajr kura.
English: This medicine is the same as Oxybee, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Oxybee, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: The most common side effect with Dany's BienenWohl (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths.
Maltese: L-effett sekondarju l-aktar komuni b'Dany's BienenWohl (li jista' jaffettwa aktar minn kolonja tan-naħal 1 minn kull 10) hu għadd akbar ta' mwiet tan-naħal.
English: How does Dany's BienenWohl work?
Maltese: Kif jaħdem Dany's BienenWohl?
English: Dany's BienenWohl (oxalic acid)
Maltese: Għaliex Dany's BienenWohl ġie awtorizzat fl-UE?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/14/955/001 Lymphoseek
Maltese: Użu minn ġol-ġilda, Użu fit-tumur, Użu madwar it-tumur, Użu għal taħt il-ġilda
English: EU/1/14/955/002 Lymphoseek
Maltese: Numru tal-EMA Isem (ivvintat)
English: EMA/520080/2010 EMEA/H/C/000732
Maltese: EMEA/H/C/000732
English: The full EPAR for Silgard 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: human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Maltese: vaċċin tal-papillomavirus uman [tipi 6, 11, 16, 18] (rikombinanti, assorbit)
English: Silgard is a vaccine.
Maltese: Silgard huwa vaċċin.
English: This document is a summary of the European public assessment report (EPAR) for Silgard.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Silgard.
English: Silgard contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Maltese: Silgard fih il-proteini L1 purifikati għat-tipi 6, 11, 16 u 18 tal-HPV, li huma prodotti b'metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA': dawn isiru minn ċelloli tal-ħmira li fihom tkun ġiet introdotta ġene (DNA) li tagħmilhom kapaċi jipproduċu l-proteini L1.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silgard on 20 September 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Silgard valida fl-Unjoni Ewropea kollha fl-20 ta' Settembru 2006.
English: A similar effect of Silgard was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Maltese: Silgard wera effetti simili meta l-analiżi inkludiet ukoll leżjonijiet taċ-ċerviċi minħabba ż-żewġ tipi l-oħra tal-HPV (it-tipi 6 u 11).
English: Three studies of Silgard given as three doses looked at the ability of Silgard to prevent infection with HPV types 6, 11, 16 and 18 and genital lesions caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Maltese: Tliet studji ta' Silgard mogħti bħala tliet dożi ffokaw fuq l-abbiltà ta' Silgard li jipprevjeni infezzjoni mittipi 6, 11, 16 u 18 tal-HPV u leżjonijiet ġenitali kkawżati minn dawn it-tipi tal-HPV fi kważi 4,000 mara ta' bejn l-24 u l-45 sena, kif ukoll fuq l-iżvilupp ta' antikorpi għal kontra dawn it-tipi tal-HPV f'madwar 1,700 tifel u tifla ta' bejn id-disa' snin u l-15-il sena.
English: Silgard is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Maltese: Silgard jintuża f'irġiel u nisa mill-età ta' disa' snin għall-protezzjoni kontra l-kondizzjonijiet li ġejjin ikkawżati minn tipi speċifiċi ta' papillomavirus uman (HPV):
English: A risk management plan has been developed to ensure that Silgard is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Silgard jintuża bl-aktar mod sigur possibbli.
English: Other information about Silgard:
Maltese: Tagħrif ieħor dwar Silgard:
English: In four main studies of Silgard given as three doses, Silgard was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Maltese: F'erba' studji ewlenin ta' Silgard mogħti bħala tliet dożi, Silgard tqabbel ma' plaċebo (vaċċin finta) fi kważi 21,000 mara ta' bejn is-16 u s-26 sena.
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Silgard who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Maltese: Fl-erba' studji f'21,000 mara, minn aktar minn 8,000 mara li ngħataw il-vaċċin ta' Silgard li qatt ma kienu infettati mit-tipi 6, 11, 16 jew 18 tal-HPV qabel, mara waħda żviluppat leżjonijiet prekanċerużi fiċ-ċerviċi li setgħu kienu kaġun tat-tipi 16 jew 18 tal-HPV.
English: What benefit has Silgard shown during the studies?
Maltese: X'benefiċċju wera Silgard matul l-istudji?
English: Finally, a main study in around 4,000 boys and men from 16 to 26 years of age compared the vaccine against placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Maltese: Fl-aħħar nett, studju ewlieni f'madwar 4,000 tifel u raġel ta' bejn is-16 u s-26 sena qabbel il-vaċċin mal-plaċebo biex jiġi ttestjat l-effett tal-vaċċin fil-prevenzjoni ta' felul ġenitali, leżjonijiet anali prekanċerużi u kanċer anali.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18
Maltese: Il-kejl ewlieni tal-effikaċja kien l-iżvilupp ta' antikorpi kontra t-tipi 6, 11, 16 u 18 tal-HPV xahar wara l-aħħar
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate
Maltese: Ma kien hemm l-ebda każ ta' kanċer anali fl-istudju iżda huwa mistenni li l-protezzjoni kontra leżjonijiet anali prekanċerużi tinbidel fi protezzjoni kontra l-kanċer.
English: In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Maltese: Fl-istudji, l-effetti sekondari l-aktar komuni b'Silgard (li dehru f'iktar minn pazjent 1 minn kull 10) kienu wġigħ ta' ras u reazzjonijiet fis-sit tal-injezzjoni (ħmura, uġigħ u nefħa).
English: In the three studies on genital lesions 2 women out of almost 8,000 in the Silgard group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Maltese: Fit-tliet studji dwar leżjonijiet ġenitali żewġ nisa minn kważi 8,000 fil-grupp ta' Silgard żviluppaw felul ġenitali, u ma kienx hemm każijiet ta' leżjonijiet prekanċerużi tal-vulva jew il-vaġina.
English: The CHMP decided that Silgard's benefits are greater than its risks and recommended that it be given
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Silgard huma akbar mir-riskji tiegħu u rrakkomanda li jingħata
English: In addition, the results confirmed the ability of Silgard to protect against lesions and HPV infection in 24- to 45-year-old women.
Maltese: Dan jgħin fil-protezzjoni kontra l-mard ikkawżat minn dawn il-virusis.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better
Maltese: Il-vaċċin fih ukoll ‘adjuvant' (taħlita li fiha l-aluminju) biex jistimola rispons aħjar.
English: For the full list of all side effects reported with Silgard, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati b'Silgard, ara l-fuljett ta' tagħrif.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you receive Nimenrix.
Maltese: Dan il-fuljett inkiteb b'mod li jassumi li qed taqrah il-persuna li se tirċievi l-vaċċin, iżda huwa jista' jingħata lill-adulti u lit-tfal għaldaqstant inti tista' kun qed taqrah għal ibnek/bintek.
English: 44 micrograms
Maltese: 44 mikrogramma
English: 1 year CSR Q1 2017 3 year CSR Q1 2019 5 year CSR Q1 2021
Maltese: 1 sena CSR Q1 2017 3 snin CSR Q1 2019
English: GlaxoSmithKline Biologicals S.A. Parc de la Noire Epine 20, rue Fleming
Maltese: S.A. Parc de la Noire Epine 20, rue Fleming
English: België/Belgique/Belgien Luxembourg/Luxemburg
Maltese: België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V.