FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Plenadren.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Plenadren.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Plenadren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Because the number of patients with adrenal insufficiency is low, the disease is considered ‘rare', and Plenadren was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Maltese: Billi l-għadd ta' pazjenti li jbatu mill-insuffiċjenza adrenali huwa baxx, il-marda hi meqjusa “rari” u Plenadren ġie kklassifikat bħala “mediċina orfni” (mediċina użata fil-mard rari) fit-22 ta' Mejju 2006.
English: The usual daily dose ranges from 20 to 30 mg, once per day early in the morning; tablets should be swallowed whole with a glass of water at least 30 minutes before food.
Maltese: Id-doża ġenerali ta' kuljum tvarja bejn 20 u 30 mg, darba kuljum filgħodu kmieni; il-pilloli għandhom jinbelgħu sħaħ ma' tazza ilma mill-30 minuta wabel l-ikel.
English: Why is Plenadren approved?
Maltese: Għaliex ġie approvat Plenadren?
English: The most common side effects with Plenadren (seen in more than 1 patient in 10) are fatigue (tiredness), diarrhoea, vertigo (feeling dizzy) and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Plenadren (li dehru f'aktar minn pazjent 1 minn kull 10) huma għejja, dijarea, vertigo (tħossok strodut) u wġigħ ta' ras.
English: The active substance in Plenadren, hydrocortisone, is the pharmaceutical form of cortisol, the main steroid hormone secreted by the adrenal gland.
Maltese: Is-sustanza attiva f'Plenadren, l-idrokortiżon, hija l-forma farmaċewtika tal-kortisol, l-ormon talisterojd ewlieni li jitnixxa mill-glandola adrenali.
English: The effects of Plenadren were investigated in one main study involving 64 patients with adrenal insufficiency.
Maltese: L-effetti ta' Plenadren kienu investigati fi studju ewlieni wieħed li kien jinvolvi 64 pazjent b'insuffiċjenza adrenali.
English: Adrenal insufficiency (including primary insufficiency or Addison's disease) is a condition where the adrenal glands (located just above the kidneys) do not produce enough of a steroid hormone called cortisol (also known as the stress hormone because it is released in response to stress).
Maltese: L-insuffiċjenza adrenali (li tinkludi insuffiċjenza primarja jew il-marda ta' Addison) hija kondizzjoni fejn il-glandoli adrenali (li jinsabu ftit 'il fuq mill-kliewi) ma jipproduċux biżżejjed mill-ormon tal-isterojd imsejjaħ kortiżol (magħruf ukoll bħala l-ormon tal-istress peress li jiġi rilaxxat meta jkun hemm l-istress).
English: Plenadren is a medicine used to treat adrenal insufficiency in adults.
Maltese: Plenadren huwa mediċina li tintuża fil-kura ta' insuffiċjenza adrenali fl-adulti.
English: What are the risks associated with Plenadren?
Maltese: X'inhuma r-riskji assoċjati ma' Plenadren?
English: Hydrocortisone replaces the natural cortisol that is missing in patients with adrenal insufficiency.
Maltese: L-idrokortiżon jieħu post il-kortisol naturali li huwa nieqes fil-pazjenti b'insuffiċjenza adrenali.
English: Plenadren, given once per day, was compared with conventional hydrocortisone treatment, which is given three times per day.
Maltese: Plenadren, mogħti darba kuljum, tqabbel mal-kura konvenzjonali tal-idrokortiżon, li tingħata tliet darbiet kuljum.
English: The overall amount of cortisol absorbed into the blood was around 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatment.
Maltese: L-ammont ġenerali tal-kortiżol assorbit fiddemm kien ta' madwar 20% inqas f'pazjenti li kienu qed jieħdu Plenadren meta mqabbel ma' pazjenti li kienu qed jieħdu l-kura konvenzjoanli tal-idrokortiżon.
English: It has been used in medicines for several decades.
Maltese: Dan ilu jintuża f'mediċini għal diversi deċennji.
English: For the full list of all side effects and restrictions with Plenadren, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Plenadren, ara l-fuljett ta' tagħrif.
English: The CHMP concluded that the benefits of Plenadren were greater than its risks and recommended that it be granted marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Plenadren huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What measures are being taken to ensure the safe and effective use of Plenadren?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Plenadren?
English: Because it is available as a modified-release tablet, Plenadren releases hydrocortisone over a longer period of time allowing for a once-daily dosing.
Maltese: Minħabba li hu disponibbli bħala pillola ta' rilaxx modifikat, Plenadren jirrilaxxa l-idrokortiżon fuq medda itwal ta' żmien li tippermetti doża ta' darba kuljum.
English: Symptoms include weight loss, muscle weakness, fatigue, low blood pressure, and sometimes darkening of the skin.
Maltese: Is-sintomi jinkludu t-telf tal-piż, dgħjufija fil-muskoli, għejja, pressjoni tad-demm baxxa, u kultant tiskura l-ġilda.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota li Plenadren kiseb livelli sodisfaċenti ta' kortiżol waqt il-kura ta' pazjenti b'insuffiċjenza adrenali.
English: How does Plenadren work?
Maltese: Kif jaħdem Plenadren?
English: It is not intended to provide practical advice on how to use Plenadren.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Plenadren.
English: EMA/790709/2014 EMEA/H/C/001235
Maltese: EMEA/H/C/001235
English: The full EPAR for Ristfor 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: Ristfor sitagliptin / metformin hydrochloride
Maltese: Ristfor sitagliptina / metformina kloridrata
English: It is available as tablets (50 mg sitagliptin and 850 mg metformin hydrochloride; 50 mg sitagliptin and 1,000 mg metformin hydrochloride).
Maltese: Jiġi bħala pilloli (50 mg sitagliptina / 850 mg metformina kloridrata; u 50 mg sitagliptina / 1,000 mg metformina kloridrata).
English: Sitagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Maltese: Is-sitagliptina hija inibitur dipeptidyl peptidase -4 (DPP 4).
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 13.8% of patients and with insulin in 10.9% of patients.
Maltese: L-ipogliċemija ġiet irrapportata bl-użu tas-sulfonilurea f'13.8% tal-pazjenti u f'10.9% tal-pazjenti bl-użu tal-insulina.
English: Other information about Ristfor:
Maltese: Informazzjoni oħra dwar Ristfor:
English: Serious side effects reported with Ristfor include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Maltese: L-effetti sekondarji serji li ġew irrapportarti bl-użu ta' Ristfor inkludew pankreatite (infjamazzjoni talfrixa) u ipersensittività (reazzjonijiet allerġiċi).
English: • in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin
Maltese: • flimkien ma' sulfonilurea, agonista PPAR gamma bħal thiazolidinedione jew insulina (tipi oħra ta'
English: Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Maltese: Iż-żieda ta' 100 mg sitagliptina flimkien malmetformina naqqset il-livelli tal-HbA1c b'0.67% (minn madwar 8.0%) wara 24 ġimgħa, meta mqabbla ma' tnaqqis ta' 0.02% fil-pazjenti li żiedu l-plaċebo.
English: Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007 and as Tesavel since 2008.
Maltese: Is-sitagliptina waħedha ilha awtorizzata fl-Unjoni Ewropea (UE) bħala Januvia u Xelenia sa mill-2007 u bħala Tesavel mill-2008.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ristfor on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ristfor fil-15 ta' Marzu 2010.
English: The active substances in Ristfor, sitagliptin and metformin hydrochloride, each have a different mode of action.
Maltese: Is-sustanzi attivi f'Ristfor, is-sitagliptina u l-metformina kloridrat, tiżvolġi azzjoni differenti.
English: Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients.
Maltese: Żewġ studji minnhom eżaminaw issitagliptina bħala żieda mal-metformina: l-ewwel wieħed qabbilha ma' plaċebo (trattament finta) f'701 pazjent, u t-tieni qabbilha ma' glipizide (sulfonilurea) f'1,172 pazjent.
English: Why has Ristfor been approved?
Maltese: Għaliex ġie approvat Ristfor?
English: This document is a summary of the European Public Assessment Report (EPAR) for Ristfor.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ristfor.
English: A risk management plan has been developed to ensure that Ristfor is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Ristfor jintuża bl-aktar mod sigur possibbli.
English: How is Ristfor used?
Maltese: Kif jaħdem Ristfor?
English: Ristfor should be taken with food to avoid any stomach problems caused by metformin.
Maltese: Ristfor għandu jittieħed mal-ikel sabiex jiġu evitati problemi tal-istonku kkawżati minn metformina.
English: Ristfor is a diabetes medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Maltese: Ristfor huwa mediċina għad-dijabete li fiha żewġ sustanzi attivi, is-sitagliptina u l-metformina kloridrata.
English: The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Maltese: It-tielet studju qabbel issitagliptina ma' plaċebo, meta użata bħala żieda ma' glimepiride (sulfonilurea oħra), bil-metformina jew mingħajrha, f'441 pazjent.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Maltese: Taħdem billi timblokka t-tkissir ta' ormoni ‘inkretini' fil-ġisem.
English: • in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
Maltese: • f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti bil-metformina biss (mediċina għad-dijabete);
English: Ristfor must not be used in patients who have diabetic ketoacidosis or pre coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Maltese: Ristfor ma għandux jintuża f'pazjenti li jbatu minn ketoaċidożi dijabetika jew prekoma (kondizzjonijiet perikolużi li jistgħu jseħħu fid-dijabete), problemi bil-fwied jew bil-kliewi, kundizzjonijiet li jistgħu jaffettwaw il-kliewi, jew marda li tikkawża provvista mnaqqsa ta' ossiġnu lit-tessuti bħal insuffiċjenza kardijaka jew tal-pulmun jew attakk tal-qalb reċenti.
English: If Ristfor is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Maltese: Jekk Ristfor jittieħed flimkien ma' sulfonilurea jew l-insulina, id-doża ta' sulfonilurea jew l-insulina jista' jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Ristfor is taken twice a day.
Maltese: Ristfor jittieħed darbtejn kuljum.
English: In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: mediċina għad-dijabete) f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti b'din il-mediċina u metformina.
English: EMA/622300/2010 EMEA/V/C/002230
Maltese: EMEA/V/C/002230
English: There can be a slight rise in body temperature, usually no more than 1 °C, in the 24 hours following vaccination.
Maltese: Jista' jkun hemm żieda ħafifa fit-temperatura tal-ġisem, normalment ta' mhux aktar minn 1 ℃, fl-24 siegħa wara t-tilqima.
English: BTVPUR AlSap 1 contains bluetongue virus of one types (‘serotype 1').
Maltese: BTVPUR AlSap 1 fih tip wieħed ta' vajrus tal-bluetongue (‘serotip 1').
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 1 to convert to a normal status.
Maltese: Fl-2013 is-CVMP qies li d-dejta mressqa kienet adegwata sabiex l-awtorizzazzjoni ta' BTVPUR AlSap 1 tinbidel għal status normali.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for BTVPUR AlSap 1 on 17 December 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal BTVPUR AlSap 1 fis-17 ta' Diċembru 2010.
English: Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks.
Maltese: It-tilqim jista' jkun segwit minn nefħa lokali żgħira fis-sit tal-injezzjoni, li normalment tgħaddi fi żmien ħames ġimgħat.
English: BTVPUR AlSap 1 is a vaccine.
Maltese: BTVPUR Alsap 1 huwa vaċċin.
English: The CVMP concluded that the benefits of BTVPUR AlSap 1 exceed the risks for active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotype 1, and recommended that BTVPUR AlSap 1 be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' BTVPUR AlSap 1 jisbqu r-riskji għal tilqim attiv ta' nagħaġ u baqar biex jipprevjeni l-infezzjoni, il-viremija u s-sinjali kliniċi kkawżati mis-serotip 1 tal-vajrus tal-lingwablu u rrakkomanda li BTVPUR AlSap 1 għandu jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: BTVPUR AlSap 1 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges..
Maltese: BTVPUR AlSap 1 jintuża fin-nagħaġ u l-bovini biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu trażmess mill-insetti dipteri.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan ilprodott tinstab fuq it-tikketta/il-pakkett ta' barra.
English: The company also presented results from a series of trials conducted with vaccines of similar composition but including different serotypes from the one in BTVPUR AlSap 1 in order to extrapolate further conclusions on the effectiveness of the vaccine.
Maltese: Il-kumpanija ppreżentat ukoll riżultati minn serje ta' provi li saru b'vaċċini b'kompożizzjoni simili iżda li jinkludu serotipi differenti minn dak f'BTVPUR AlSap 1 biex testrapola aktar konklużjonijiet dwar l-effikaċja.
English: Inactivated adjuvanted vaccine against bluetongue disease virus serotype 1
Maltese: Vaċċin aġġuvantat inattivat kontra s-serotip 1 tal-marda tal-vajrus tallingwablu
English: In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly.
Maltese: Fil-futur, jekk lannimali jkunu esposti għall-virus tal-lingwablu, is-sistema immunitarja tkun kapaċi tipproduċi antikorpi aktar malajr.
English: What is BTVPUR AlSap 1?
Maltese: X'inhu BTVPUR AlSap 1?
English: The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotype 1.
Maltese: L-istudji juru li l-vaċċin huwa sigur għan-nagħaġ u l-baqar u li jnaqqas is-sinjali tal-mard u jipprevjeni l-viremija fl-annimali li għandhom sena u li huma infettati bis-serotip 1 tal-vajrus tal-bluetongue.
English: BTVPUR AlSap 1 was initially authorised under ‘exceptional circumstances'.
Maltese: Għall-ewwel BTVPUR AlSap 1 ġie awtorizzat taħt ‘ċirkostanzi eċċezzjonali'.
English: Results also from a series of laboratory safety trials performed with vaccines of similar composition but including different bluetongue serotypes (including studies in pregnant ewes and cows) were presented in order to extrapolate safety conclusions.
Maltese: Ġew ippreżentati wkoll riżultati minn serje ta' provi ta' sigurtà fillaboratorju li saru b'vaċċini ta' kompożizzjoni simili iżda li jinkludu serotipi differenti tal-lingwablu (fosthom studji f'nagħaġ u baqar tqal) biex jiġu estrapolati konklużjonijiet dwar is-sigurtà.
English: What is the risk associated with BTVPUR AlSap 1?
Maltese: X'riskji huma assoċjati ma' BTVPUR AlSap 1?
English: The benefitrisk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji jista' jiġi kkonsultat fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: Other information about ProteqFlu-Te:
Maltese: Informazzjoni oħra dwar ProteqFlu-Te:
English: Telephone +44 (0)20 3660 8400 Facsimile +44 (0)20 3660 8447 E-mail info@ema.europa.eu Website www.ema.europa.eu
Maltese: 3660 8447 E-mail info@ema.europa.eu Website www.ema.europa.eu
English: The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te on 6 March 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal ProteqFlu-Te fis-6 ta' Marzu 2003.
English: This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted in to the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains.
Maltese: Dan ifisser li ġene minn żewġ razez differenti tal-influwenza ekwina (A/eq/Ohio/03 u A/eq/Richmond/1/07) iddaħħal fil-virusis vetturi tal-canarypox, li ma jipproduċux marda fiż-żwiemel, biex b'hekk il-vettur seta' jipproduċi proteini speċifiċi minn dawn ir-razez tal-influwenza.
English: ProteqFlu-Te is available as a suspension for injection.
Maltese: ProteqFlu-Te huwa disponibbli bħala sospensjoni għall-injezzjoni.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jista' jinstab fil-modulu taddiskussjoni xjentifika f'dan l-EPAR.
English: Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani.
Maltese: It-tetnu huwa marda akuta, ħafna drabi fatali kkawżata min-newrotossina tal-batterju Clostridium tetani.
English: In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitive product).
Maltese: Fl-istudji fil-laboratorju, iż-żwiemel ġew sfidati (infettati) bil-virus tal-influwenza ekwina u s-sinjali kliniċi u l-eskrezzjoni tal-virus tal-influwenza wara l-isfida tqabblu bejn annimali mlaqqma u annimali ta' kontroll (annimali mhux imlaqqma jew annimali mlaqqma bi prodott kompetittiv).
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti wkoll mill-EPAR).
English: ProteqFlu-Te is a vaccine which was produced with the use of recombinant DNA technology.
Maltese: ProteqFlu-Te huwa vaċċin li ġie prodott bl-użu ta' teknoloġija rikombinanti tad-DNA.
English: It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium).
Maltese: Fih partijiet minn żewġ razez tal-influwenza (flu) ekwina, li ddaħħlu f'żewġ virusis vetturi (ġarriera) tal-canarypox rispettivament, u tossojd tat-tetnu (tossini mdgħajfa kimikament mill-batterju tat-tetnu).
English: What is ProteqFlu-Te?
Maltese: X'inhu ProteqFlu-Te?
English: Why has ProteqFlu-Te been approved?
Maltese: Għaliex ġie approvat ProteqFlu-Te?
English: The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Maltese: Il-marda, li ġeneralment toriġina minn ġrieħi kontaminati, hija kkaratterizzata minn riġidità (ebusija) ġenerali u spażmi konvulsivi tal-muskoli.
English: What is the risk associated with ProteqFlu-Te?
Maltese: X'inhu r-riskju assoċjat ma' ProteqFlu-Te?
English: The studies showed that ProteqFlu-Te was effective in reducing clinical signs and virus excretion after infection with equine influenza, and against tetanus to prevent mortality from 14 days after primary vaccination.
Maltese: L-istudji wrew li ProteqFlu-Te kien effiċjenti fit-tnaqqis tas-sinjali kliniċi u l-eskrezzjoni tal-virus wara l-infezzjoni bl-influwenza ekwina, u kontra t-tetnu biex jipprevjeni l-mortalità minn 14-il jum wara t-tilqima primarja.
English: How has ProteqFlu-Te been studied?
Maltese: Kif ġie studjat ProteqFlu-Te?
English: The vaccine also stimulates protection against tetanus to prevent mortality.
Maltese: Il-vaċċin jistimula wkoll il-protezzjoni kontra t-tetnu biex jipprevjeni l-mortalità.
English: Equine influenza and tetanus vaccine
Maltese: Vaċċin kontra l-influwenza ekwina u t-tetnu
English: The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Maltese: Il-vaċċin inaqqas is-sinjali kliniċi tal-influwenza ekwina u l-eskrezzjoni (tixrid) talvirus wara l-infezzjoni.
English: The current formulation of ProteqFlu-Te produced similar antibody responses against the two flu strains and tetanus toxoid included in the vaccine to those seen in the main studies.
Maltese: Il-formulazzjoni attwali ta' ProteqFlu-Te pproduċiet risponsi tal-antikorpi kontra ż-żewġ razez talinfluwenza u t-tossojd tat-tetnu inklużi fil-vaċċin li huma simili għal dawk li kien hemm fl-istudji ewlenin.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu-Te exceed the risks for the approved indication and recommended that ProteqFlu-Te be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' ProteqFlu huma akbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li ProteqFlu jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The effectiveness of ProteqFlu-Te was first assessed in several laboratory and field studies.
Maltese: Għall-ewwel, l-effikaċja ta' ProteqFlu-Te ġiet ivvalutata f'diversi studji fil-laboratorju u fuq il-post.
English: In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).
Maltese: F'każ ta' riskju akbar ta' infezzjoni jew teħid insuffiċjenti ta' kolostru (l-ewwel ħalib), tista' tingħata injezzjoni inizjali oħra fl-età ta' 4 xhur, segwita mill-programm sħiħ ta' tilqim (tilqima primarja u t-tilqimiet mill-ġdid ta' wara).
English: ProteqFlu-Te is a vaccine for use in horses.
Maltese: ProteqFlu-Te huwa vaċċin għall-użu fiż-żwiemel.