FrancophonIA/ELRC3.0 huggingface dataset:
English: The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against distemper, adenovirus, parvovirosis and kennel cough in addition to other diseases to demonstrate effectiveness of Versican Plus DHPPi.
Maltese: L-istudju prattiku involva l-kombinazzjonijiet ta' vaċċini akbar Versican Plus DHPPi/L4 u Versican Plus DHPPi/L4R, li huma wkoll maħsuba biex jipproteġu kontra distempra, adenovirus, parvovirus u kennel cough apparti mard ieħor, biex juru l-effikaċja ta' Versican Plus DHPPi.
English: • canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough.
Maltese: • virus tal-parainfluwenza tal-klieb u adenovirus tal-klieb tip 2, li jikkawżaw il-‘kennel cough';
English: This will help protect them against distemper, adenovirus liver infection, parvovirosis and kennel cough.
Maltese: Dan se jgħin jipproteġihom kontra distempra, infezzjoni tal-fwied minn adenovirus, parvovirus u kennel cough.
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 iktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra ddiskussjoni xjentifika (parti wkoll mill-EPAR).
English: Versican Plus DHPPi is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2.
Maltese: Versican Plus DHPPi huwa vaċċin veterinarju li fih il-virus tad-distempra tal-klieb, l-adenovirus tip 2 talklieb, il-parvovirus tip 2b tal-klieb u l-virus tal-parainfluwenza tip 2 tal-klieb ħaj attenwat (imdgħajjef).
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Maltese: L-effett sekondarju l-aktar komuni (li deher f'iktar minn 1 minn kull 100 kelb) b'Versican Plus DHPPi huwa nefħa għal żmien qasir sa 5 cm li tista' sseħħ fil-post tal-injezzjoni wara t-tilqima.
English: Canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated)
Maltese: Tilqima tad-distempra tal-klieb, adenovirus tal-klieb, parvovirus tal-klieb u parainfluwenza virus tal-klieb (ħaj attenwat)
English: Responses in puppies were lower than in adult dogs in some cases, because of antibodies inherited from their mothers since maternal antibodies may block the immune response to vaccination.
Maltese: Ir-reazzjonijiet fil-ġriewi kienu aktar baxxi milli fil-klieb adulti f'ċertu każi minħabba antikorpi li ntirtu minn ommhom, peress li antikorpi maternali jistgħu jimblokkaw ir-reazzjoni immunitarja għattilqima.
English: • canine adenovirus type 1, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
Maltese: • adenovirus tal-klieb tip 1, li jikkawża infezzjoni akuta tal-fwied li tista' toħloq sinjali ta' suffejra (sfurija tal-ġilda u l-għajnejn);
English: • canine distemper, an infectious disease which is sometimes called ‘hard pad' since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting, diarrhoea, excessive salivation and in some cases fits;
Maltese: • distempra tal-klieb, marda infettiva li xi drabi tissejjaħ ‘hard pad' minħabba li l-klieb jistgħu jiżviluppaw ħxuna fil-ġilda tal-pads tas-saqajn, kif ukoll imnieħer iqattar, sogħla, deni, rimettar, dijarea, bżieq eċċessiv u f'xi każijiet aċċessjonijiet;
English: What is the risk associated with Versican Plus DHPPi?
Maltese: X'riskji huma assoċjati ma' Versican Plus DHPPi?
English: Versican Plus DHPPi is used to protect dogs against:
Maltese: Versican Plus DHPPi jintuża biex jipproteġi lill-klieb kontra:
English: What is Versican Plus DHPPi?
Maltese: X'inhu Versican Plus DHPPi?
English: Why has Versican Plus DHPPi been approved?
Maltese: Għaliex ġie approvat Versican Plus DHPPi?
English: Other information about Versican Plus DHPPi:
Maltese: Tagħrif ieħor dwar Versican Plus DHPPi:
English: Versican Plus DHPPi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.
Maltese: Versican Plus DHPPi huwa disponibbli bħala lijofilizzat (pellit imnixxfa bl-iffriżar) b'solvent li jitħalltu flimkien f'sospensjoni għal injezzjoni.
English: The field study showed that vaccination with Versican Plus DHPPi resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Maltese: Studju prattiku wera li tilqima b'Versican Plus DHPPi rriżultat f'livelli ta' antikorpi li kienu suffiċjenti biex jipproteġu kontra virus tad-distempra tal-klieb u adenovirus tal-klieb fil-klieb kollha.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi exceed the risks for the approved indications and recommended that Versican Plus DHPPi be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Versican Plus DHPPi huma akbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li Versican Plus DHPPi jingħata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: Versican Plus DHPPi is a vaccine.
Maltese: Versican Plus DHPPi huwa tilqima.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi on 4 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Versican Plus DHPPi fl-4 ta' Lulju 2014.
English: The full EPAR for Zomarist can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Zomarist jinsab fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Maltese: F'Settembru 2007, il-vildagliptin kien ġie approvat waħdu mill-UE bl-isem ta' Galvus, filwaqt li lmetformina ilha disponibbli fl-UE sa mill-1959.
English: Patients adding vildagliptin had a fall in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Maltese: Il-pazjenti li żiedu l-vildagliptin kellhom tnaqqis fil-livelli ta' HbA1c ta' 0.88% punti perċentwali wara 24 ġimgħa minn livell tal-bidu li kien 8.38%.
English: This is a summary of the European public assessment report (EPAR) for Zomarist.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zomarist.
English: Zomarist is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Maltese: Zomarist huwa mediċina li fiha s-sustanzi attivi vildagliptin u metformina kloridrat (metformin hydrochloride).
English: Why has Zomarist been approved?
Maltese: Għaliex ġie approvat Zomarist?
English: The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Maltese: L-effetti sekondarji l-aktar komuni b'Zomarist (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżja (dardir), remettar, dijarrea, uġigħ addominali (ta' żaqq) u telf tal-aptit.
English: What is Zomarist?
Maltese: X'inhu Zomarist?
English: In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.3%.
Maltese: B'kuntrast ta' dan, il-pazjenti li żiedu l-plaċebo kellhom bidliet iżgħar fil-livelli ta' HbA1c, b'żieda ta' 0.23 % punti perċentwali minn livell tal-bidu ta' 8.3%.
English: How has Zomarist been studied?
Maltese: Kif ġie studjat Zomarist?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zomarist on 1 December 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Zomarist valida fl-Unjoni Ewropea kollha fl-1 ta' Diċembru 2008.
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Zomarist in the same indications.
Maltese: L-istudji b'Galvus bħala terapija aġġuntiva għall-metformina, il-metformina u s-sulfonilurea, jew il-metformina u l-insulina ntużaw bħala sostenn għall-użu ta' Zomarist fl-istess indikazzjonijiet.
English: The studies compared Galvus with placebo and measured 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: Listudji qabblu Galvus mal-plaċebo u kejlu l-livelli ta' sustanza fid-demm magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni dwar kemm qed jiġi kkontrollat tajjeb il-glukożju fid-demm.
English: It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their 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: M'għandux jintuża f'pazjenti li jbatu minn ketoaċidożi dijabetika (livelli għoljin ta' ketoni u aċidi fid-demm), prekoma dijabetika, problemi bil-fwied jew bilkliewi, kondizzjonijiet li jistgħu jaffettwaw il-kliewi, jew marda li tikkawża provvista mnaqqsa ta' ossiġenu lit-tessuti bħal insuffiċjenza tal-qalb jew tal-pulmun jew attakk tal-qalb reċenti.
English: What is the risk associated with Zomarist?
Maltese: X'inhu r-riskju assoċjat ma' Zomarist?
English: Elderly patients taking Zomarist should have their kidney function monitored regularly.
Maltese: Il-pazjenti anzjani li jkunu qed jieħdu Zomarist għandu jkollhom il-funzjoni tal-kliewi ssorveljata regolarment.
English: The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.
Maltese: Il-kumpanija li tipproduċi Eucreas qablet li d-dejta xjentifika tagħha tista' tintuża għal Zomarist.
English: Other information about Zomarist
Maltese: Kif jintuża Zomarist?
English: Taking Zomarist with or just after food may reduce any stomach problems caused by metformin.
Maltese: Meta wieħed jieħu Zomarist mal-ikel jew eżatt wara, jistgħu jitnaqqsu problemi tal-istonku kkawżati mill-metformina.
English: The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Maltese: Is-CHMP ikkonkluda li l-vildagliptin meħud mal-metformina jnaqqas l-livelli ta' glukożju fid-demm u lkombinazzjoni taż-żewġ sustanzi attivi f'pillola waħda tista' tgħin lill-pazjenti sabiex iżommu mattrattament tagħhom.
English: This medicine is the same as Eucreas, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Eucreas, li huwa diġà awtorizzat fl-Unjoni Ewropea (UE).
English: List of antiretrovirals: abacavir; abacavir, dolutegravir, lamivudine; abacavir; abacavir, lamivudine, zidovudine; atazanavir; atazanavir, cobicistat; bictegravir, emtricitabine, tenofovir alafenamide; darunavir; darunavir, cobicistat; darunavir, cobicistat, emtricitabine, tenofovir alafenamide; didanosine; dolutegravir; dolutegravir, rilpivirine; efavirenz ; efavirenz, emtricitabine, tenofovir disoproxil; elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil; emtricitabine; emtricitabine, rilpivirine, tenofovir alafenamide; emtricitabine, rilpivirine, tenofovir disoproxil; emtricitabine, tenofovir alafenamide; emtricitabine, tenofovir disoproxil; enfuvirtide; etravirine; fosamprenavir; indinavir; lamivudine; lamivudine, tenofovir; lamivudine, zidovudine; lopinavir, ritonavir; maraviroc; nevirapine; raltegravir; rilpivirine; ritonavir; saquinavir; stavudine; tenofovir disoproxil; tipranavir; zidovudine
Maltese: Lista ta' antiretrovirali: abacavir; abacavir, dolutegravir, lamivudine; abacavir; abacavir, lamivudine, zidovudine; atazanavir; atazanavir, cobicistat; bictegravir, emtricitabine, tenofovir alafenamide; darunavir; darunavir, cobicistat; darunavir, cobicistat, emtricitabine, tenofovir alafenamide; didanosine; dolutegravir; dolutegravir, rilpivirine; efavirenz; efavirenz, emtricitabine, tenofovir disoproxil; elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil; emtricitabine; emtricitabine, rilpivirine, tenofovir alafenamide; emtricitabine, rilpivirine, tenofovir disoproxil; emtricitabine, tenofovir alafenamide; emtricitabine, tenofovir disoproxil; enfuvirtide; etravirine; fosamprenavir; indinavir; lamivudine; lamivudine, tenofovir; lamivudine, zidovudine; lopinavir, ritonavir; maraviroc; nevirapine; raltegravir; rilpivirine; ritonavir; saquinavir; stavudine; tenofovir disoproxil; tipranavir; zidovudine
English: Antiretrovirals - Autoimmune hepatitis (EPITT no 18956)
Maltese: Antiretrovirali - Epatite awtoimmuni (EPITT nru 18956)
English: Human normal immunoglobulin for intravenous administration (IVIg) - Lupus-like syndrome and related terms (EPITT no 19098)
Maltese: Immunoglobina normali tal-bniedem għal amministrazzjoni ġol-vina - Sindrome bħal tal-lupus u termini relatati (EPITT nru 19098)
English: Adopted at the 9-12 July 2018 PRAC
Maltese: Adottati fil-PRAC tad-9-12 ta' Lulju 2018
English: Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin.
Maltese: Ġew osservati każijiet ta' meninġite asettika riversibbli u każijiet rari ta' reazzjonijiet tal-ġilda temporanji (inkluż eritematożu tal-lupus tal-ġilda - frekwenza mhux magħrufa) b'immunoglobina normali tal-bniedem.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja gravi meta jibdew taħlita ta' terapija antiretrovirali (CART), tista' tirriżulta reazzjoni infjammatorja għal patoġeni bla sintomi jew opportunistiċi residwali u din tista' tikkaġuna kundizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja severa meta jibdew CART, tista' tirriżulta reazzjoni ta' infjammazzjoni għal patoġeni bla sintomi jew dawk opportunistiċi residwali.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Maltese: Disturbi awtoimmuni (bħall-marda ta' Graves u epatite awtoimmuni) ġew irrappurtati wkoll; madankollu, iż-żmien irrappurtat sal-bidu hu iktar varjabbli u dawn l-avvenimenti jistgħu jseħħu ħafna xhur wara l-bidu talkura (ara sezzjoni 4.4).
English: EMEA/V/C/043
Maltese: EMEA/V/C/043 RAPPORT TA' VALUTAZZJONI
English: Foxes
Maltese: Volpijiet
English: This summary was last updated in May 2008.
Maltese: Mejju 2008.
English: The number of baits distributed depends on the number of foxes or raccoon dogs and varies between 13 and 20 per square kilometre.
Maltese: L-għadd ta' lixki li jitferrxu jiddependi millgħadd ta' volpijiet jew klieb rakkun u jvarja bejn 13 u 20 lixka għal kull kilometru kwadru.
English: Rabigen SAG2 is used for the active immunisation of red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides) to prevent infection by rabies virus.
Maltese: Rabingen SAG2 jintuża għall-immunizzazzjoni attiva tal-volpijiet ħomor (Vulpes vulpes) u tal-klieb rakkun (Nyctereutes procyonoides) għall-prevenzjoni mill-infezzjoni tal-vajrus tarrabbja.
English: Rabigen SAG2 is a vaccine.
Maltese: Rabigen SAG2 huwa vaċċin.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RABIGEN SAG2 EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) RABIGEN
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Rabigen SAG2 to Virbac S.A. on 6 April 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rabigen SAG2 lil Virbac S.A. fis-6 ta' April 2000.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Rabigen SAG2 exceed the risks for its use in red foxes and raccoon dogs to prevent infection by rabies virus and recommended that Rabigen SAG2 be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Rabigen SAG2 huma akbar mir-riskji għall-użu tiegħu f'volpijiet ħomor u fi klieb rakkun għall-prevenzjoni ta' infezzjoni mill-vajrus tar-rabbja u rrakkomanda li Rabigen SAG2 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is Rabigen SAG2?
Maltese: X'inhu Rabigen SAG2?
English: What is the risk associated with Rabigen SAG2?
Maltese: Għal xiex jintuża Rabigen SAG2?
English: The marketing authorisation was subsequently renewed in 2005 and varied in April 2008 to include raccoon dogs as a new target species.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet sussegwentement imġedda fl-2005 u modifikata f'April 2008 biex tinkludi l-klieb rakkun bħala speċi ġdida fil-mira.
English: Why has Rabigen SAG2 been approved?
Maltese: Għaliex ġie approvat Rabigen SAG2?
English: Other information about Rabigen SAG2:
Maltese: Tagħrif ieħor dwar Rabigen SAG2:
English: Rabigen SAG2 can only be used by authorised personnel within the framework of vaccination campaigns against rabies.
Maltese: Rabigen SAG2 jista' jintuża esklussivament minn persunal awtorizzat bħala parti millkampanji ta' tilqim kontra r-rabbja.
English: Rabigen SAG2 is a vaccine againts rabies.
Maltese: Rabigen fih vajrusis talrabbja ħajjin.
English: How has Rabigen SAG2 been studied?
Maltese: Kif ġie studjat Rabigen SAG2?
English: Following bait uptake, adult and fox cubs and raccoon dogs showed significant antibody response.
Maltese: Wara d-distribuzzjoni ta' madwar erba' miljun lixka tal-prodott matul il-provi fuq il-post fuq erba' snin, twettqet sorveljanza intensiva taż-żoni tat-tilqim.
English: The viruses have been selected because of their ‘low virulence' (limited ability to cause the disease).
Maltese: Il-vajrusis intgħażlu minħabba l-'virulenza baxxa' tagħhom (kapaċità limitata li jikkawżaw il-marda).
English: T1/2 (h) AUC (IU.h/dL)**
Maltese: AUC (IU.h/dL) **
English: Bayer HealthCare LLC 800 Dwight Way Berkeley
Maltese: Bayer HealthCare LLC 800 Dwight Way, Berkeley, CA 94710
English: Acetic acid, glacial (for pH adjustment)
Maltese: Acetic acid, glacial (għall-aġġustament tal-pH)
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax tinbiegħ separatament.
English: FVIII inhibition very common (PUPs)* uncommon (PTPs)*
Maltese: komuni ħafna (PUPs)* mhux komuni (PTPs)*
English: Each vial of Kovaltry contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Maltese: Kull kunjett ta' Kovaltry fih nominalment 250, 500, 1,000, 2,000 jew 3,000 IU octocog alfa.
English: Sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Maltese: Sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial u ilma għall-injezzjonijiet.
English: • the severity of your haemophilia A
Maltese: • is-severità tal-emofilja A
English: Q1 first quartile; Q3 third quartile
Maltese: Q1 l-ewwel quartile;
English: EXP (End of the 12 month period, if stored up to 25 °C): ................
Maltese: EXP (Fi tmiem perjodu ta' 12-il xahar jekk maħżun f'temperatura sa 25 °C): ...........
English: The specific activity of Kovaltry is approximately 4000 IU/mg protein.
Maltese: L-attività speċifika ta' Kovaltry hija madwar 4,000 IU/mg ta' proteina.
English: 1 multipack with 30 single packs.
Maltese: pakkett multiplu bi 30 pakkett ta' wieħed.
English: Kovaltry can be used for all age groups.
Maltese: Kovaltry jista' jintuża għall-gruppi kollha ta' età.
English: • vial adapter
Maltese: • adapter tal-kunjett
English: Factor VIII level required (%) (IU/dL)
Maltese: Livell ta' fattur VIII meħtieġ (%) (IU/dL)
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: 3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
Maltese: IU u 3,000 IU) solvent (ċilindru trasparenti ta' tip 1 b'għotjien griżi tal-gomma tal bromobutajl)
English: • syringe plunger rod
Maltese: • plunġer tas-siringa
English: For 250/500/1000 IU strength
Maltese: Għall-qawwa ta' 250/500/1,000 IU
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100).
English: • one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed it-trab (10 mL, ħġieġ trasparenti tip 1 kunjett magħluqa b'għatu griż tal-gomma tal-halogenobutyl, komponent ta' siġill u aluminju).
English: For 2000/3000 IU strength
Maltese: Għall-qawwa ta' 2,000/3,000 IU
English: Apply a tourniquet to your arm.
Maltese: Applika tourniquet fi driegħek.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests (see section 4.2).
Maltese: B'mod ġenerali l-pazjenti kkurati bi prodotti ta' fattur VIII tal-koagulazzjoni, għandhom jiġu ssorveljati bir-reqqa għall-iżvilupp ta' inibituri permezz ta' osservazzjonijiet kliniċi u testijiet tallaboratorju xierqa (ara sezzjoni 4.2).
English: Multipack with 30 single packs, each containing:
Maltese: Pakkett multiplu bi 30 pakkett ta' wieħed, li kull wieħed fih:
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.
Maltese: Kategorija farmakoterapewtika: mediċini kontra emorraġija, fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: The number of factor VIII units is expressed in International Units (IU).
Maltese: In-numru ta' unitajiet tal-fattur VIII huwa espress f'Unitajiet Internazzjonali (IU - International
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota, li r-rata annwali ta' fsada (ABR - annualised bleeding rate) mhix komparabbli bejn konċentrati ta' fatturi differenti u bejn studji kliniċi differenti.
English: Since Kovaltry is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Maltese: Billi Kovaltry hu proteina ta' sostituzzjoni ta' fattur VIII endoġenu, mhuma mistennija l-ebda effetti avversi fuq il-fertilità.
English: INFORMATION IN BRAILLE Kovaltry 2000
Maltese: INFORMAZZJONI BIL-BRAILLE Kovaltry 2000
English: INFORMATION IN BRAILLE Kovaltry 250
Maltese: INFORMAZZJONI BIL-BRAILLE Kovaltry 250