FrancophonIA/ELRC3.0 huggingface dataset:
English: Both pimobendan and benazepril are already authorised for dogs as separate medicines.
Maltese: Kemm il-pimobendan kif ukoll il-benazepril huma diġà awtorizzati għall-klieb bħala mediċini separati.
English: This can lead to exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Maltese: Dan jista' jwassal għal intolleranza għall-eżerċizzju (inabbiltà li titwettaq attività fiżika), problemi fit-teħid tan-nifs u żamma tal-fluwidi.
English: Pimobendan is an inotropic (heart stimulant) substance which increases the strength of the contraction of heart muscle and opens up blood vessels carrying blood to and from the heart, which reduces the work of the heart.
Maltese: Il-pimobendan hija sustanza inotropika (stimulant tal-qalb) li żżid is-saħħa tal-kontrazzjoni tal-muskolu tal-qalb u tiftaħ il-vini li jwasslu d-demm lejn u mill-qalb, li jnaqqas ix-xogħol għall-qalb.
English: People who are hypersensitive (allergic) to pimobendan or benazepril hydrochloride should avoid contact with Fortekor Plus.
Maltese: Il-persuni li huma ipersensittività (allerġiċi) għall-pimobendan jew il-benazapril kloridrat għandhom jevitaw kuntatt ma' Fortekor Plus.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) decided that Fortekor Plus' benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Fortekor Plus huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy.
Maltese: Nisa tqal għandhom joqgħodu attenti iktar sabiex jevitaw li aċċidentalment jibilgħu Fortekor Plus minħabba li l-inibituri tal-enzima li tikkonverti anġjotensin (ACE) instab li jaffettwaw it-tarbija fil-ġuf matul it-tqala.
English: It also must not be given to dogs with low blood pressure, low blood volume, low blood sodium levels or acute (short-term) kidney failure.
Maltese: M'għandux ukoll jingħata lil klieb bi pressjoni baxxa tad-demm, volum tad-demm baxx, livelli baxxi ta' sodju fid-demm jew indeboliment tal-kliewi akut (għal żmien qasir).
English: 12 vials Meat and offal: 15 days (cattle), 5 days (pigs, horses)
Maltese: kunjetti 12 Laħam u l-ġewwieni tal-annimali: 15-il jum (baqar), 5 ijiem (majjali, żwiemel) Ħalib: 5 ijiem (baqar)
English: 16 December 2010 EMA/792246/2010 EMEA/H/C/000859
Maltese: EMA/792246/2010
English: Emerflu contains a flu strain called ‘A/Vietnam/1194/2004 NIBRG 14' (H5N1).
Maltese: Emerflu fih razza tal-influwenza li tissejjaħ ‘A/Vietnam/1194/2004
English: Withdrawal of the marketing authorisation application for Emerflu [pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)]
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Emerflu [vaċċin tal-influwenza pandemika (H5N1) (virjonu maqsum, inattivat, b'sustanza awżiljarja)]
English: What is Emerflu?
Maltese: X'inhu Emerflu?
English: Emerflu is a vaccine.
Maltese: Emerflu huwa vaċċin.
English: Emerflu was expected to be used in adults to protect against ‘pandemic' flu.
Maltese: Emerflu kien mistenni jintuża fl-adulti biex jipproteġi kontra l-influwenza ‘pandemika'.
English: The main measure of effectiveness was the level of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Maltese: Il-kejl prinċipali tal-effikaċja kien il-livell ta' antikorpi kontra l-vajrus tal-influwenza fiddemm fi tliet perjodi differenti: qabel il-vaċċin, fil-ġurnata tat-tieni injezzjoni (jum 21) u 21 ġurnata aktar tard (jum 42).
English: Emerflu contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Maltese: Emerflu fih ammonti żgħar ta' emoagglutinini (proteini mill-wiċċ) ta' vajrus imsejjaħ H5N1.
English: On 1 December 2010, Sanofi Pasteur SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Emerflu, for the prevention of ‘pandemic' flu.
Maltese: Fl-1 ta' Diċembru 2010, Sanofi Pasteur SA għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Emerflu, għall-prevenzjoni tal-influwenza ‘pandemika'.
English: Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.
Maltese: Minħabba li lproduzzjoni ta' antikorpi wara li ngħata Emerflu kienet taħt dan il-livell fl-istudji prinċipali (inqas minn 40% fil-parteċipanti li kellhom inqas minn 60 sena), is-CHMP kien imħasseb li Emerflu ma kienx adegwat għall-użu bħala vaċċin mudell.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet il-valutazzjoni qabel ma din ġiet irtirata?
English: The CHMP was concerned over the ability of Emerflu to trigger the production of enough antibodies against the flu virus.
Maltese: Is-CHMP kien imħasseb dwar il-kapaċità ta' Emerflu li jistimula l-produzzjoni ta' biżżejjed antikorpi kontra l-vajrus tal-influwenza.
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Maltese: Skont il-kriterji stabbiliti mis-CHMP, jenħtieġ li vaċċin mudell jipproduċi livelli ta' antikorpi protettivi f'tal-inqas 70% tan-nies biex dan jitqies adegwat.
English: The main study of Emerflu included 600 healthy adults and compared the ability of two doses of Emerflu, to trigger the production of antibodies (‘immunogenicity').
Maltese: L-istudju prinċipali ta' Emerflu kien jinkludi 600 adult f'saħħithom u qabbel il-kapaċità ta' żewġ dożi ta' Emerflu li jistimulaw il-produzzjoni ta' antikorpi (‘immunoġeniċità').
English: What was Emerflu expected to be used for?
Maltese: Kif kien mistenni jaħdem Emerflu?
English: Similar results were seen in the people who received Emerflu that contained a different strain of flu virus, and there were contradictory results in the studies looking at the effects of a third dose of Emerflu.
Maltese: Riżultati simili dehru fil-persuni li rċevew Emerflu li kien fih razza differenti tal-vajrus tal-influwenza, u kien hemm riżultati kontradittorji fl-istudji li stħarrġu l-effetti tat-tielet doża ta' Emerflu.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium), which is expected to stimulate a better response.
Maltese: Ilvaċċin fih ukoll ‘sustanza awżiljarja' (taħlita li fiha l-aluminju), li tkun mistennija tistimula rispons aħjar.
English: It is a suspension for injection that contains parts of influenza (flu) viruses that have been inactivated (killed).
Maltese: Huwa sospensjoni għal injezzjoni li fih parti mill-vajrusijiet tal-influwenza (flu) li ġew inattivati (maqtula).
English: The effects of Emerflu were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Emerflu ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq il-bnedmin.
English: If a pandemic were to start, the virus strain in Emerflu would have been replaced by the strain causing the pandemic before the vaccine could have been used.
Maltese: Kien maħsub li jintuża biss ladarba l-influwenza pandemika tkun ġiet iddikjarata b'mod uffiċjali.
English: How was Emerflu expected to work?
Maltese: Għal xiex kien mistenni jintuża Emerflu?
English: A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Influwenza pandemika sseħħ meta jitfaċċa tip (razza) ġdid ta' vajrus tal-influwenza li jista' jinfirex faċilment minn persuna għal oħra għax in-nies ma jkollhom l-ebda immunità (protezzjoni) kontrih.
English: Emerflu was expected to work as a ‘mock-up' vaccine.
Maltese: Emerflu kien mistenni jaħdem bħala vaċċin ‘mudell'.
English: In addition, 100 further people received Emerflu that contained a different strain of flu virus.
Maltese: Barra minn hekk, 100 persuna oħra rċevew Emerflu li kien fih razza differenti tal-vajrus tal-influwenza.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-vajrus bħala ‘barrani' u tibni antikorpi kontrih.
English: The participants received two injections of Emerflu containing one of two different doses of haemagglutinin.
Maltese: Il-parteċipanti rċevew żewġ injezzjonijiet ta' Emerflu li kien fihom waħda miż-żewġ dożi differenti tal-emoagglutinina.
English: At that point in time, the CHMP was of the opinion that the benefits of Emerflu used for prophylaxis of influenza in an officially declared pandemic situation did not outweigh its risks.
Maltese: Dan huwa tip ta' vaċċin speċjali huwa żviluppat biex jgħin il-ġestjoni ta' pandemija.
English: They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Maltese: Imbagħad jistgħu jittestjaw dan il-vaċċin biex jaraw kif in-nies jirreaġixxu għalih, u dan jippermettilhom ibassru kif in-nies sejrin jirreaġġixxu ladarba tiġi inkluża r-razza tal-influwenza li tkun qed tikkawża l-pandemija.
English: Therefore, the Committee was also concerned that the vaccine's immunogenicity was low, regardless of the strain of virus included, and that the vaccine might not be able to adequately prepare the immune system for future infections.
Maltese: Għalhekk ilKumitat kien imħasseb ukoll li l-immunoġeniċità tal-vaċċin kienet baxxa, irrispettivament mir-razza tal vajrus inkluż, u li l-vaċċin jista' ma jkunx kapaċi jipprepara b'mod adegwat lis-sistema immunitarja kontra infezzjonijiet ġejjiena.
English: 2 x 5 pre-filled syringe without safety device s
Maltese: Mnejn jingħata Il-pakkett
English: Further information on Grasustek can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/grasustek.
Maltese: ema.europa.eu/medicines/human/EPAR/grasustek.
English: Grasustek is a ‘biosimilar medicine'.
Maltese: Grasustek huwa "mediċina bijosimili".
English: The active substance in Grasustek, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Grasustek, il-pegfilgrastim, hija forma ta' filgrastim, li hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: The reference medicine for Grasustek is Neulasta.
Maltese: Il-mediċina ta' referenza għal Grasustek hija Neulasta.
English: In addition, a study involving 248 patients who had chemotherapy after surgery for breast cancer showed that Grasustek was as effective as Neulasta in reducing the duration of neutropenia.
Maltese: Barra minn hekk, studju li involva 248 pazjent li ħadu l-kimoterapija wara kirurġija għall-kanċer tassider wera li Grasustek kien effettiv daqs Neulasta fit-tnaqqis tat-tul ta' newtropenija.
English: What are the risks associated with Grasustek?
Maltese: X'inhuma r-riskji assoċjati ma' Grasustek?
English: Laboratory studies comparing Grasustek with Neulasta have shown that the active substance in Grasustek is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Grasustek ma' Neulasta wrew li s-sustanza attiva f'Grasustek hija simili ħafna għal dik f'Neulasta f'termini ta' struttura, purità u attività bijoloġika.
English: Other information about Grasustek
Maltese: Informazzjoni oħra dwar Grasustek
English: In Grasustek, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Grasustek, filgrastim ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Grasustek huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: Grasustek is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Maltese: Grasustek mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika tal-kanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grasustek has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Grasustek għandu struttura, purità u attività bijoloġika simili ħafna għal Neulasta u jiġi distribwit bl-istess mod fil-ġisem.
English: How does Grasustek work?
Maltese: Kif jintuża Grasustek?
English: Grasustek is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.
Maltese: Grasustek huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni tal-kimoterapija tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: Filgrastim has been available in other medicines in the EU for a number of years.
Maltese: Filgrastim ilu disponibbli f'mediċini oħrajn fl-UE għal numru ta' snin.
English: For the full list of side effects and restrictions with Grasustek, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet b'Grasustek, ara l-fuljett ta' tagħrif.
English: How is Grasustek used?
Maltese: Kif jaħdem Grasustek?
English: The safety of Grasustek has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Maltese: Is-sigurtà ta' Grasustek ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji talmediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Neulasta.
English: As for all medicines, data on the use of Grasustek are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Grasustek hija ssorveljata kontinwament.
English: All these data were considered sufficient to conclude that Grasustek will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Grasustek ser jaġixxi bl-istess mod bħal Neulasta f'termini ta' effikaċja u sigurtà fl-użu approvat tiegħu.
English: Studies have also shown that giving Grasustek produces similar levels of the active substance in the body to giving Neulasta.
Maltese: L-istudji wrew ukoll li l-għoti ta' Grasustek jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Neulasta.
English: Grasustek is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of cancer treatment.
Maltese: Grasustek jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija.
English: Cattle and sheep: subcutaneous injection.
Maltese: Żmien ta' tiżmim: Laħam u ġewwieni:
English: SC (cattle, sheep), IM (pigs)
Maltese: SC (bovini, nagħaġ), IM (ħnieżer).
English: The bioavailability of gamithromycin was > 92 %.
Maltese: Il-bijodisponibilità tal-gamithromycin kienet > 92 %.
English: MIC µg/ml
Maltese: µg/ml
English: Cattle:
Maltese: Bovini:
English: Meat and offal: Cattle: 64 days Sheep: 29 days Pigs: 16 days
Maltese: Bovini: 64 ġurnata Nagħaġ: 29 ġurnata Ħnieżer: 16-il ġurnata
English: Actinobacillus pleuropneumoniae Pasteurella multocida Haemophilus parasuis Bordetella bronchiseptica Sheep
Maltese: Actinobacillus pleuropneumoniae Pasteurella multocida Haemophilus parasuis Bordetella bronchiseptica Nagħaġ
English: Date of first authorisation: 24/07/2008 Date of last renewal: 15/07/2013
Maltese: Data tal-aħħar tiġdid : 15/07/2013
English: Sheep
Maltese: Ovini
English: Meat and offal: Cattle: 64 days.
Maltese: Bovini: 64 ġurnata.
English: Gamithromycin Gamithromycin
Maltese: Gamithromycin Gamithromycin Bovini
English: Antiinfectious agents / Antibiotics
Maltese: Aġenti anti-infettivi /
English: Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.
Maltese: Kura tal-pododermatite (foot rot) assoċjata ma' Dichelobacter nodosus virulenti u Fusobacterium necrophorum li jirrikjedu kura sistemika.
English: Pharmaco-logically active substance
Maltese: Sustanza farmako loġikament attiva
English: The volume of distribution at steady-state was 25 l/kg.
Maltese: Il-volum tad-distribuzzjoni fissa kien ta' 25 l/kg.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae,Haemophilus parasuis and Bordetella bronchiseptica, the bacterial pathogens most commonly associated with BRD and SRD, and also Fusobacterium necrophorum and Dichelobacter nodosus.
Maltese: L-attività kontra l-mikrobi li tkopri spettru wiesa' tal-gamithromycin tinkludi Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae, Haemophilus parasuis u Bordetella bronchiseptica, il-patoġeni batterjali li huma ġeneralment assoċjati mal-BRD (il-marda respiratorja tal-bovini) u SRD u wkoll Fusobacterium necrophorum u
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml)
Maltese: Kaxxa tal-kartun (50ml/100ml/250ml)
English: 50 μg/kg 300 μg/kg 200 μg/kg
Maltese: 50 μg/kg 50 μg/kg 300 μg/kg 200 μg/kg
English: Active substance: 150 mg of gamithromycin Excipients: 1 mg of monothioglycerol Colourless to pale yellow solution.
Maltese: Sustanza attiva: 150 mg ta' gamithromycin, Sustanza mhux attiva: 1mg ta' monothioglycerol.
English: Cardboard box containing 1 vial of 50, 100, 250 or 500 ml.
Maltese: Kaxxa tal-kartun li fiha kunjett ta' 50, 100, 250 jew 500 ml.
English: Excipient:
Maltese: Doża eċċessiva:
English: Sheep: 29 days.
Maltese: Nagħaġ: 29 ġurnata.
English: In young adult cattle, sheep and pig studies, gamithromycin was administered by injection at 6, 18, and 30 mg/kg (1, 3, and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three times the recommended duration of use).
Maltese: Fi studju fuq bovini u ħnieżer adulti żgħar, gamithromycin ġie amministrat b'injezzjoni ta' 6, 18 u 30 mg/kg (darba, tlieta u ħames darbiet id-doża rakkomandata) u ripetuta tliet darbiet f'0, 5 u 10 jiem (tliet darbiet tat-tul tal-użu rakkomandat).
English: The bioavailability of the compound was > 98 % with no gender differences.
Maltese: Il-bijodisponibilità tal-komponent kienet > 98 % mingħajr differenzi ta' sess.
English: • Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: • Rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: Cattle, pigs
Maltese: Bovini, ħnieżer
English: The volume of distribution at steady-state was approximately 39 l/kg.
Maltese: Il-volum tad-distribuzzjoni fissa kien ta' madwar 39 l/kg.
English: In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Pharmacotherapeutic group: Antibacterials for systemic use, macrolides ATC vet code: QJ01FA95.
Maltese: Kodici ATC veterinarja QJ01FA95.
English: Type 1 glass vial of 50, 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal.
Maltese: Kunjett tal-ħġieġ ta' Tip I ta' 50, 100, 250 jew 500 ml b'għeluq tal-chlorobuty , tapp tal-polipropillin u għeluq ippjegat tal-aluminju..
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti mhux attivi
English: 1 ml contains 150 mg of gamithromycin
Maltese: Millilitru fih 150 mg ta' gamithromycin
English: • Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Maltese: • Mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat)
English: Pigs: 16 days.
Maltese: Ħnieżer: 16-il ġurnata.
English: People with known hypersensitivity to the macrolide class should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għall-klassi tal-makrolidi għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: In vitro plasma protein binding studies determined that the mean concentration of the free active substance was 74 %.
Maltese: Studji in vitro dwar l-abbinar tal-proteini mal-plasma wrew li l-konċentrazzjoni medja tas-sustanza attiva libera kienet ta' 74 %.
English: In vitro plasma protein binding studies determined that the mean concentration of the free active drug was 77 %.
Maltese: Studji in vitro dwar l-abbinar tal-proteini mal-plasma wrew li l-konċentrazzjoni medja tas-sustanza attiva libera kienet ta' 77 %.
English: 1 ml contains 150 mg of gamithromycin,
Maltese: 1 ml fih 150 mg ta' gamithromycin,
English: Biliary excretion of the unchanged drug substance was the major route of elimination.
Maltese: It-tneħħija mill-marrara tas-sustanza mediċinali mhux alterata kienet ilmod prinċipali ta' eliminazzjoni.
English: Polypropylene vial of 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal.
Maltese: Kunjett tal-polipropillin ta' 100, 250 jew 500 ml b'għeluq tal-cholorobutyl tapp tal-polipropillin u għeluq ippjegat tal-aluminju.
English: Porcine 100 μg/kg 100 μg/kg
Maltese: SUINA 100 μg/kg
English: Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Maltese: Evita li tamministra flimkien antimikrobiċi li għandhom l-istess mod t'azzjoni bħal makrolidi oħra jew linkosamidi.
English: During clinical trials transient injection site swellings were observed.
Maltese: Waqt provi kliniċi, xi nefħiet transitorji fil-post tal-injezzjoni ġew osservati.
English: The cap may be safely punctured up to 60 times.
Maltese: It-tapp jista' jittaqqab b'mod sikur sa' 60 darba.
English: 1 ml contains
Maltese: 1ml fih
English: Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.
Maltese: Kura tal-marda respiratorja fil-ħnieżer (SRD) assoċjata mal-Actinobacillus pleuropneumoniae, Pasturella multocida Haemophilus parasuis u Bordetella bronchiseptica.
English: Gamithromycin may cause irritation to eyes and/or skin.
Maltese: Gamithromycin jista' jikkawża irritazzjoni fl-għajnejn u/jew fil-ġilda.