FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Maltese: Il-medja tar-reżistenza vaskulari pulmonari kienet imnaqqsa b'mod sinifikattiv fil grupp ta' bosentan (b'effett predominanti osservat fis-sottogrupp ta' pazjenti b'shunt intrakardijaku bi direzzjonali).
English: There is limited experience with abrupt discontinuation of Tracleer in patients with PAH.
Maltese: Hemm esperjenza limitata dwar it-twaqqif f'daqqa ta' Tracleer f'pazjenti b'PAH.
English: Concomitant use of Tracleer and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Maltese: L-użu ta' Tracleer flimkien ma' cyclosporine A huwa kontraindikat (ara sezzjonijiet 4.3 u 4.5).
English: Tracleer 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 125 mg ta' bosentan (bħala monohydrate).
English: A bioavailability comparison between dispersible tablets and film-coated tablets performed in adult subjects indicated lower exposure to bosentan with the dispersible tablet (see section 5.2).
Maltese: Paragun tal-bijodisponibiltà bejn pilloli li jinxterdu u pilloli miksija b'rita li twettaq f'individwi adulti indika esponiment aktar baxx għal bosentan bil-pillola li tinxtered (ara sezzjoni 5.2).
English: This may be harmful for people with phenylketonuria.
Maltese: Dan jista' jkun ta' ħsara għall-persuni b'phenylketonuria.
English: Aug ______
Maltese: Ġun ______
English: An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
Maltese: Studju dwar l interazzjoni bejn bosentan u lopinavir+ritonavir f'individwi f'saħħithom wera konċentrazzjonijiet ta' bosentan fil-plażma miżjuda, bil-livell massimu waqt l-ewwel 4 ijiem ta' kura (ara sezzjoni 4.5).
English: Because Tracleer may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Maltese: Peress li Tracleer jista' jirrendi l-kontraċezzjoni ormonali (eż. orali, injezzjoni, impjant jew gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda) mhux effettiva, dan il-metodu waħdu mhux affidabbli.
English: At the same timepoints, 88% and 79% of patients remained free from PAH worsening (defined as all-cause death, lung transplantation, atrial septostomy or start of intravenous or subcutaneous prostanoid treatment).
Maltese: Fl-istess żmien, 88% u 79% tal-pazjenti baqgħu ħielsa minn irkadar ta' PAH (definita bħala mewt ta' kull kawża, trapjant tal-pulmun, septostomija atrijali jew bidu ta' kura bi prostanoid fil vini jew taħt il-ġilda).
English: When treatment with Tracleer is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests.
Maltese: Meta tinbeda kura bi Tracleer f'pazjenti li jeħtieġu inibituri ta' protease msaħħa b'ritonavir, fil-bidu tal-fażi ta' inizjazzjoni t-tolleranza tal-pazjent għal Tracleer għandha tiġi mmonitorjata mill-viċin b'attenzjoni speċjali, għar-riskju ta' pressjoni baxxa u għal testijiet tal-funzjoni tal-fwied.
English: Dyspnoea measurement during walk tests showed an improvement in bosentan-treated patients.
Maltese: Imbotta l-prodott mediċinali minn ġol-folja.
English: Tracleer 125 mg film-coated tablets bosentan
Maltese: Tracleer 125 mg pilloli miksija b'rita bosentan
English: Patients and prescribers must be aware that due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Maltese: Pazjenti u tobba għandhom ikunu jafu li, minħabba interazzjonijiet farmakokinetiċi potenzjali, hemm il-possibbiltà li Tracleer ineħħi l-effetti tal-kontraċettivi ormonali (ara sezzjoni 4.5).
English: The efficacy of Tracleer has not been established in patients with severe PAH.
Maltese: L-effikaċja ta' Tracleer ma ġietx stabbilita f'pazjenti li għandhom PAH severa.
English: Jun ______
Maltese: Aww ______
English: The most common adverse reaction was headache of mild to moderate intensity.
Maltese: L-aktar reazzjoni avversa komuni kienet uġigħ ta' ras ħafif sa moderat.
English: Because of possible hormonal contraception failure during Tracleer treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Maltese: Minħabba l-possibbiltà ta' falliment ta' kontraċezzjoni ormonali waqt kura b'Tracleer, kif ukoll b'konsiderazzjoni tar-riskju li pressjoni pulmonari għolja tista' tiddeterjora b'mod sever bit tqala, hu rakkomandat li jsiru testijiet tat-tqala kull xahar matul il-kura bi Tracleer biex tkun possibbli s-sejba bikrija tat-tqala.
English: Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations.
Maltese: Avvenimenti avversi ta' anormalitajiet fil-fwied u anemija\
English: Excipient
Maltese: Dijarea
English: These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with Tracleer (see section 4.4).
Maltese: osservazzjoni stretta tal-iskeda ta' kull xahar ta' sorveljanza tal-funzjoni tal-fwied għat-tul tal-kura b'Tracleer (ara sezzjoni 4.4).
English: If the decision to withdraw Tracleer is taken, it should be done gradually while an alternative therapy is introduced.
Maltese: Jekk tittieħed deċiżjoni li jitwaqqaf Tracleer, dan għandu jsir b'mod gradwali waqt li tinbeda terapija alternattiva.
English: Eisenmenger's physiology
Maltese: IL-PRODOTT MEDIĊINALI
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking Tracleer.
Maltese: Jekk hemm possibbiltà li toħroġ tqila, uża mezz affidabbli ta' kontroll tat-twelid (kontraċezzjoni) waqt li tkun qed tieħu Tracleer.
English: Control was placebo plus current therapy.
Maltese: Il-kontroll kien il-plaċebo flimkien mat terapija kurrenti.
English: The terminal elimination halflife (t1/2) is 5.4 hours.
Maltese: Ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija (ara sezzjonijiet 5.1 u 5.2).
English: Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking Tracleer.
Maltese: Kontroll tat-twelid ibbażat fuq l-ormoni - bħal kontraċettivi orali jew pilloli għallkontroll tat-twelid, injezzjonijiet tal-ormoni, impjanti, jew garża li tipprovdi mediċina għall-kontroll tat-twelid li tgħaddi minn ġol-ġilda ma jipprevenux it-tqala b'mod affidabbli f'nisa li qed jieħdu Tracleer.
English: For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C.
Maltese: Għall-folji tal-PVC/PE/PVDC/aluminju:
English: 0.120 mg/0.015 mg per 24 h depotlääkevalmiste, emättimeen
Maltese: 015 mg per 24 h depotlääkevalmiste, emättimeen
English: Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78
Maltese: Ir-Repubblika Ċeka
English: Vial (glass) 100 ml
Maltese: 100 mL Kunjett wieħed
English: Meat and offal: 53 days
Maltese: Laħam u ġewwieni tal-annimali 53 jum.
English: Piglets
Maltese: Perjodu ta' tiżmim
English: EU (MA) number Invented name
Maltese: Numru tal-EMA Isem ivvintat
English: EU/1/11/741/001 Levetiracetam SUN 100 mg/ml
Maltese: EU/1/11/741/001 Levetiracetam SUN 100 mg/ml konċentrat għal soluzzjoni għallinfużjoni
English: Active substance: Cabergoline ....................................................................... 1.12 mg
Maltese: Cabergoline ....................................................................... 1.12 mg
English: Date of first authorisation: 09/12/2015
Maltese: Data tal-ewwel awtorizzazzjoni: 09/12/2015
English: Cabergoline Bovine 0.10 µg/kg 0.25 µg/kg
Maltese: Cabergoline Cabergoline Bovin 0.10 µg/kg 0.25 µg/kg
English: Dimethyl sulfoxide Triglycerides, medium-chain
Maltese: Dimethyl sulfoxide Trigliċeridi, katina medja
English: More than 74% of cabergoline is bound to plasma protein.
Maltese: Aktar minn 74% ta' cabergoline hu marbut ma' proteini fil-plażma.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 1.12 mg/ml
Maltese: ATTIVA(I) 1.12 mg/ml
English: The active substance in Velactis is cabergoline, an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Velactis hi cabergoline, sustanza permessa kif deskritta f'tabella 1 tal-anness tar-Regolament tal-Kummissjoni(UE) Nru 37/2010:
English: Approximately 66% of the administered dose is eliminated by faeces.
Maltese: Madwar 66% tad-doża amministrata tiġi eliminata mal-ippurgar.
English: Pharmacologically active substance
Maltese: Sustanza farmakoloġika ment attiva
English: Excipients: For the full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1
English: Urine is the second pathway of elimination.
Maltese: L-awrina hija t-tieni rotta t'eliminazzjoni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/192/001-004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/15/192/001-004
English: In vitro, some macrolide antibiotics, like erythromycin, inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
Maltese: In vitro, xi antibijotiċi makrolidi, bħal erythromycin, impedew l-attività tal-enzimi bovini ta' cytochrom P-450 (sottoklassi CYP3A4).
English: Pack sizes:
Maltese: Perjodu ta' Tiżmim:
English: Studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.
Maltese: Studji fuq annimali tal-laboratorju wrew riskju ta' mewt embrijonika wara esponiment orali ripetut għal cabergoline.
English: Only use a dry sterile needle and avoid the introduction of humidity/water during use.
Maltese: Uża biss labra sterili niexfa u evita l-introduzzjoni ta' umdità/ilma waqt l-użu.
English: Interactions with other medicinal products and other forms of interaction In vitro, some macrolide antibiotics like erythromycin inhibited the activity of bovine Cytochrom P 450-enzymes (CYP3A4-subclass).
Maltese: Interazzjonijiet ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni In vitro, xi antibijotiċi makrolidi, bħal erythromycin, impedew l-attività tal-enzimi bovini ta' cytochrom P-450 (sottoklassi CYP3A4).
English: Prolactin inhibitor
Maltese: PARIR SABIEX
English: (There are no data on pregnancy outcome in humans following injection of cabergoline, but studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.)
Maltese: (M'hemmx tagħrif dwar eżitu ta' tqala fil-bniedem wara injezzjoni ta' cabergoline, imma studji fl-annimali tal-laboratorju wrew riskju ta' mewt embrijonika wara esponiment orali ripetut ta' cabergoline.)
English: The difference between groups was 13.7% (95% confidence interval 6.4-21%).
Maltese: Id-differenza bejn gruppi kienet ta' 13.7% (intervall ta' kunfidenza ta' 95% 6.4-21%).
English: cabergoline
Maltese: IEĦOR
English: It acts on dopamine receptors of prolactin producing cells in the pituitary gland suppressing the prolactin production and leading to the inhibition of prolactin secretion dependent process.
Maltese: Huwa jaġixxi fuq riċettaturi ta' dopamine ta' ċelluli li jipproduċu prolactin fil-glandola pitwitarja bi trażżin tal-produzzjoni ta' prolactin u li jwassal għall-impediment ta' proċess dipendenti fuq it-tnixxija ta' prolactin.
English: Cardboard box of 5 ml vial Cardboard box of 25 ml vial Cardboard box of 50 ml vial Cardboard box of 5x5 ml vials
Maltese: Kaxxa tal-kartun b'kunjett ta' 5 ml Kaxxa tal-kartun b'kunjett ta' 25 ml Kaxxa tal-kartun b'kunjett ta' 50 ml Kaxxa tal-kartun b'5 kunjetti ta' 5 ml
English: Cardboard box with 1 vial of 5 ml, 25 ml or 50 ml, or 5 vials of 5 ml.
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 5 ml, 25 ml jew 50 ml, jew 5 kunjetti ta' 5 ml.
English: In a multicentric randomized clinical trial where dairy cows with no intramammary infections at the time of drying-off were administered either Velactis or placebo at the time of drying-off, the incidence of new intramammary infections within 7 days after subsequent calving was significantly lower among udder quarters of cows treated with Velactis (20.5%) as compared to placebo (26.0%).
Maltese: Fi prova klinika, multiċentrika u każwali fejn baqar tal-ħalib mingħajr infezzjonijiet intramammarji fiż-żmien li ma kinux jaħilbu ngħataw jew Velactis jew plaċebo, l-inċidenza ta' infezzjonijiet intramammarji ġodda fi żmien 7 ijiem wara t-twelid sussegwenti kien b'mod sinjifikanti aktar baxx fost kwarti ta' bżieżel ta' baqar trattati b'Velactis (20.5%) meta mqabbla ma' plaċebo (26.0%).
English: Clear pale yellow solution.
Maltese: Soluzzjoni safra pallida ċara.
English: The difference in occurrence of pain was 9.9% (95% confidence interval 4.0-15.8%) between the Velactis treated cows compared to placebo treated animals.
Maltese: Id-differenza fil-manifestazzjoni ta' wġigħ kienet ta' 9.9% (intervall ta' kunfidenza ta' 95% 4.0-15.8%) bejn baqar trattati b'Velactis meta mqabbla ma' annimali trattati bi plaċebo.
English: Pharmacotherapeutic group: Other gynaecologicals, prolactin inhibitors, cabergoline ATCvet code: QG02CB03
Maltese: Mediċini ġinekoloġi oħrajn, impedituri tal-prolactin, cabergoline Kodiċi ATCvet:
English: The veterinary medicinal product may cause skin sensitization.
Maltese: Il-prodott mediċinali veterinarju jista' jikkaġuna sensibilizzazzjoni tal-ġilda.
English: - 4 days (8 milkings) after calving when the dry period length is less than 32 days
Maltese: - 4 ijiem (8 ħalbiet) wara t-twelid meta t-tul tal-perjodu xott ikun inqas minn 32 jum
English: Overdose (symptoms, emergency procedures, antidotes), if necessary Overdoses resulted in some cases in slight and transient decrease of appetite.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Dożi eċċessivi rriżultaw f'xi każijiet żgħar u temporanji ta' nuqqas t'aptit.
English: In a randomized and placebo controlled clinical study, reduced discomfort was demonstrated during the first day after drying-off by increasing daily lying time by 143 +/- 17 minutes in Velactis treated animals in comparison with untreated controls.
Maltese: Fi studju kliniku każwali u bilplaċebo bħala kontroll, skonfort imnaqqas ġie manifestat waqt l-ewwel jum wara t-tnixxif b'żieda filħin ta' mteddd b'143 +/- 17-il minuta f'annimali trattati b'Velactis meta mqabbla ma' kontrolli mhux ittrattati,
English: Cabergoline is rapidly metabolized principally by liver, and is eliminated with a mean half-life of about 20 h.
Maltese: Cabergoline jiġi metabolizzat malajr prinċipalment fil-fwied, u jiġi eliminat b'half-life medja ta' madwar 20 siegħa.
English: The difference between groups was 8.7% (95% confidence interval 4.9-12.6%).
Maltese: Id-differenza bejn il-gruppi kienet ta' 8.7% (intervall ta' kunfidenza ta' 95% 4.9-12.6%).
English: Pack sizes
Maltese: Tessuti mmirat i
English: This was confirmed in another multicentric randomized clinical trial where incidence of milk leakage was significantly lower among Velactis treated animals (3.9%) as compared to placebo treated animals (17.6%).
Maltese: Dan ġie kkonfermat bi prova klinika każwali u multiċentrika oħra fejn l-inċidenza ta' tnixxija ta' ħalib kienet b'mod sinjifikanti aktar baxxa fost annimali trattati b'Velactis (3.9%) meta mqabbla ma' annimali trattati bi plaċebo (17.6%).
English: Three consecutive administrations of 1, 3 or 5 times the recommended dose may result in transient and reversible slight elevation of plasma glucose levels.
Maltese: Tliet għotjiet konsekkutivi ta' 1, 3 u 5 darbiet id-doża rakkomandata tista' tirriżulta f'livelli temporanji ta' glukozju fil-plażma kemxejn ogħla u riversibbli.
English: Fatal meteorism has been observed in a single cow following a second administration of 5 times the recommended dose.
Maltese: Meteoriżmu fatali ġie osservat f'baqra waħda wara t-tieni għotja ta' 5 darbiet id-doża rakkomandata.
English: The difference in percentage of new intramammary infections during the dry period between Velactis treated animals and the placebo group was 5.5% (95% confidence interval 0.5-10.4%).
Maltese: Id-differenza fil-perċentwali ta' infezzjonijiet intramammarji ġodda waqt il-perjodu xott bejn annimali trattati b'Velactis u l-grupp tal-plaċebo kien ta' 5.5% (intervall ta' kunfidenza ta' 95% ta' 0.5-10.4%).
English: At 9 times the recommended dose a decrease in ruminal activity may be observed.
Maltese: F'9 darbiet id-doża rakkomandata tnaqqis flattività ruminali kien ġie osservat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection cabergoline
Maltese: VETERINARJU Velactis 1.12 mg/ml soluzzjoni għall-injezzjoni cabergoline
English: The administration of three or five times the recommended dose for 3 consecutive days (i.e. corresponding to 9 and 15 times the recommended dose, respectively) resulted in addition in some cases in transient and reversible digestive signs such as diarrhoea.
Maltese: L-għoti ta' minn tlieta sa ħames darbiet id-doża rakkomandata għal 3 ijiem konsekuttivi (i.e li tikkorispondi għal 9 sa 15-il darba d-doża rakkomandata, rispettivament) irriżultat f'xi każijiet ta' sinjali diġestivi riversibbli u temporanji bħal dijarea.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għal ġol-muskoli
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: Meat and offal: 23 days
Maltese: Laħam u ġewwieni tal-annimali: 23 jum
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml contains 1.12 mg of cabergoline.
Maltese: OĦRA 1 ml fih 1.12 mg cabergoline
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-eċċipjenti elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: 4.9 Amounts to be administered and administration route
Maltese: 4.9 Ammonti li għandhom jingħataw u l-metodu ta' amministrazzjoni
English: Liver Kidney Muscle Milk
Maltese: Użu għal ġol-muskoli.
English: This could theoretically decrease the metabolisation of cabergoline, and prolong its persistence in plasma from cows treated concomitantly with Velactis and such products.
Maltese: Dan teoretikament jista' jnaqqas il-metaboliżmu ta' cabergoline, u jtawwal il-persistenza tiegħu fil-plażma fuq baqar li ġew trattati fl-istess waqt b'Velactis u prodotti bħalu.
English: Cabergoline is a synthetic ergot derivative, which is a potent dopamine receptor agonist on D2 receptors.
Maltese: Cabergoline huwa derivat tal-ergot sintetiku, li hu agonista qawwi tar-riċettatur ta' dopamine f'riċettaturi D2.
English: Brown glass vials closed by bromobutyl stoppers and crimped with aluminium and plastic flip capsules.
Maltese: Kunjetti tal-ħġieġ kannella b'tappijiet tal-bromobutyl u rbattut b'kapsuli tal-aluminju u l-plastik li jinfetħu bis-saba'.
English: After intramuscular administration in cattle, the systemic absorption of cabergoline is rapid and important (bioavailability over 90%), with a peak concentration observed around 3 h after administration and followed by a high tissue distribution.
Maltese: Wara l-għoti ġol-muskoli fl-ifrat, l-assorbiment sistemiku ta' cabergoline hu malajr u importanti (bijodisponibilità ta' aktar minn 90%), b'konċentrazzjoni li tilħaq il-quċċata osservata madwar 3 sigħat wara l-għoti u segwit b'distribuzzjoni għolja fit-tessut.
English: INDICATION
Maltese: TIKKETTAR
English: The efficacy of Velactis in reducing the risk of new intramammary infections during the dry period when administered concomitantly with antimicrobial treatment to cows with intramammary infections has not been investigated compared to antimicrobial treatment alone.
Maltese: L-effikaċja ta' Velactis fit-tnaqqis ta' infezzjonijiet intramammarji ġodda waqt il-perjodu xott meta jingħata ma' trattament antimikrobijali fl-istess waqt fil-baqar b'infezzjonijiet intramammarji ma ġietx mistħarrġa meta mqabbla ma trattament waħdu.
English: ADVICE ON CORRECT ADMINISTRATION Normal aseptic procedures for administration of an intramuscular injection should be followed.
Maltese: B'MOD KORRETT Proċeduri asettiċi normali għall-għoti ta' injezzjoni ġol-muskolu għandhom jiġu segwiti.
English: Each ml contains:
Maltese: Kull ml fih:
English: Consequently, cabergoline administration induces a reduction of milk production leading to a reduction in udder engorgement and intramammary pressure.
Maltese: Konsegwentement, l-għoti ta' cabergoline jinduċi tnaqqis fil-produzzjoni ta' ħalib li jwassal għal tnaqqis fil-mili bil-bżieżel u pressjoni intramammarja.
English: For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to: - reduce milk leakage at drying off, - reduce the risk of new intramammary infections during the dry period, - reduce discomfort.
Maltese: Għal użu fi programm ta' ġestjoni tal-merħla ta' baqar tal-ħalib bħala għajnuna għall-tnixxif f'daqqa bi tnaqqis tal-produzzjoni tal-ħalib għal: - tnaqqis ta' tnixxija ta' ħalib fit-tnixxif - tnaqqis fir-riskju ta' infezzjonijiet intramammarji ġodda waqt il-perjodu ta' tnixxif, - tnaqqis fl-iskonfort.
English: Label of 25 ml vial
Maltese: Tikketta ta' kunjett ta' 25 ml
English: For the 25 ml, 50 ml and the 5x5ml only: Once broached, use within 28 days.
Maltese: Għal 25 ml, 50 ml u l-5x5 ml biss: Ladarba jinfetaħ, uża fi żmien 28 jum
English: Velactis reduces milk production.
Maltese: Velactis inaqqas il-produzzjoni tal-ħalib.
English: For cows considered likely to be free of subclinical mastitis at drying off, in which antibiotic use is not justified/permitted, Velactis can be used as a dry cow treatment.
Maltese: Għal baqar ikkunsidrati li huma ħielsa minn mastite sottoklinika fil-perjodu li mhumiex jaħilbu, meta l-użu ta' antibijotiku mhux ġustifikat/permess, Valactis jista' jintuża bħala trattament għal baqar li mhux jaħilbu.
English: Label of 50 ml vial
Maltese: Tikketta ta' kunjett ta' 50 ml
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/)
English: The full EPAR for Emend 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: This summary was last updated in 11-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 11-2015.
English: Emend is a neurokinin 1 (NK1) receptor antagonist.
Maltese: Emend huwa antagonist tar-riċetturi tal-newrokinina 1 (neurokinin 1 receptor antagonist, NK1).
English: Emend is a medicine containing the active substance aprepitant.
Maltese: Emend huwa mediċina li fiha s-sustanza attiva aprepitant.
English: Other information about Emend
Maltese: Informazzjoni oħra dwar Emend