FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of TXA.
Maltese: Is-CHMP ikkunsidra wkoll il-profil ta' reazzjonijiet avversi, inkluż avvenimenti avversi ġodda (xi wħud minnhom serji) assoċjati mal-użu ta' TXA.
English: The latest quality review of documents templates were taken into account during this review.
Maltese: L-aħħar reviżjoni tal-kwalità tal-mudelli taddokumenti ttieħdet f'kunsiderazzjoni matul din ir-reviżjoni.
English: In particular the therapeutic indications were updated to reflect current scientific knowledge on the use of TXA; other changes to the product information were inclusion information on disseminated intravascular coagulation, visual disturbances including impaired colour vision, thromboembolism, haematuria and convulsions as warnings and recommendations.
Maltese: B'mod partikolari, l-indikazzjonijiet terapewtiċi ġew aġġornati biex jirriflettu l-għarfien xjentifiku attwali dwar l-użu ta' TXA; tibdil ieħor fl-informazzjoni dwar il-prodott kien l-inklużjoni ta' informazzjoni dwar koagulazzjoni intravaskulari mxerrda, disturbi viżwali inkluż indeboliment fil-viżjoni tal-kulur, tromboemboliżmu, ematurja u konvulżjonijiet bħala twissijiet u rakkomandazzjonijiet.
English: One MAH for tranexamic acid containing medicinal products expressed its disagreement with the CHMP Opinion, focusing its grounds for re-examination on the following points:
Maltese: Detentur wieħed tal-awtorizzazzjoni għat-tqegħid fis-suq għal prodotti mediċinali li fihom tranexamic acid wera li ma jaqbilx mal-Opinjoni tas-CHMP, u ffoka r-raġunijiet tiegħu għal eżaminazzjoni mill-ġdid fuq il-punti li ġejjin:
English: The same is applicable for fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding.
Maltese: L-istess huwa applikabbli għal kundizzjonijiet fibrinolitiċi wara koagulopatija ta' konsum ħlief f'dawk b'attivazzjoni predominanti tas-sistema fibrinolitika bi fsada severa akuta.
English: The Committee considered that evidence from randomised clinical trials and observational studies support the use of tranexamic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Maltese: • Il-Kumitat ikkunsidra li l-evidenza minn provi kliniċi randomizzati u mill-istudji ta' osservazzjoni tappoġġa l-użu ta' tranexamic acid f'pazjenti li għaddejjin minn proċeduri dentali jew kirurġiċi jew li qegħdin f'riskju ta' komplikazzjonijiet minn fsada.
English: In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of TXA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Maltese: Minbarra l-kirurġija tal-qalb, is-CHMP ikkunsidra li hemm biżżejjed evidenza disponibbli dwar is-sigurtà u l-effikaċja ta' TXA f'indikazzjonijiet oħra, inkluż f'pazjenti li għaddejjin minn proċeduri dentali jew kirurġiċi jew li qegħdin f'riskju ta' kumplikazzjonijiet minn fsada.
English: 1855 Luxembourg
Maltese: 1855 Lussemburgu
English: 00330 Helsinki Finland
Maltese: 00330 Helsinki Finlandja
English: Rzymowskiego 34 02 - 697 Warszawa Poland
Maltese: Rzymowskiego 34 02 - 697 Warszawa Polonja
English: 811 09 Bratislava Slovak Republic
Maltese: 811 09 Bratislava Slovakkja
English: Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
Maltese: Westlaan 142 2909 LD Capelle a/d Ijssel
English: Hungary Pfizer Kft. Alkotás u. 53.
Maltese: Ungerija Pfizer Kft. Alkotás u. 53.
English: Porto Salvo 2470 Oeiras Portugal
Maltese: Porto Salvo 2470
English: Member State EU/EEA
Maltese: Membru UE/ZEE
English: Ramstage Road
Maltese: Ramsgate Road
English: 23/25 Avenue Du Docteur Lannelongue 75014 Paris France
Maltese: 23/25 Avenue Du Docteur Lannelongue 75014
English: PFIZER ITALIA Via Valbiondone 113 00188 Roma Italy
Maltese: Via Valbiondone 113 00188 Roma
English: Pfizer Trading Polska Sp. z o. o. ul.
Maltese: Pfizer Trading Polska Sp. z o. o.
English: PFIZER HELLAS A.E Mesogion Av 242 15451 N.Psichiko Greece
Maltese: PFIZER HELLAS A.E Mesogion Av 242 15451 N.Psichiko Greċja
English: 3 syringes 12 syringes 24 syringes 300 syringes 350 syringes
Maltese: 3 siringi 12-il siringa 24 siringa 300 siringa
English: Slovenia PFIZER Luxembourg SARL
Maltese: Slovenja PFIZER Luxembourg SARL
English: Prednisolone is an anti-inflammatory corticosteroid.
Maltese: Prednisolone huwa kortikosterojd anti-infjammatorju.
English: SYNULOX L.C. (200mg + 50mg + 10mg)/3g, zawiesina dowymieniowa, bydło
Maltese: (200mg + 50mg + 10mg)/3g, zawiesina dowymieniowa, bydło
English: Animals were slaughtered at 12, 24, 36, 48 and 72 hours after the last treatment.
Maltese: L-annimali inqatlu fit-12, 24, 36, 48 u 72 siegħa wara l-aħħar kura.
English: The comparator product had a different composition (cloxacillin-ampicillin combination).
Maltese: Il-prodott komparatur kellu kompożizzjoni differenti (kombinazzjoni ta' cloxacillin-ampicillin).
English: Calcium Sodium Aluminosilicate (dried) Mineral Oil (Formula A)
Maltese: Calcium Sodium Aluminosilicate (niexef) Żejt minerali (Formula A)
English: Pfizer Luxembourg SARL, o.z.
Maltese: Slovakkja Pfizer Luxembourg SARL, o.z.
English: Pfizer Oy Animal Health Tietokuja 4
Maltese: Norveġja Pfizer Oy Animal Health Tietokuja 4
English: Ireland Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy
Maltese: Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy County Cork Irlanda
English: Do not store above 25°C.
Maltese: Aħżen f'temperaturi anqas minn 25C.
English: Emulsifying Wax White Soft Paraffin Liquid Paraffin Light
Maltese: Emulsifying Wax Paraffin Abjad Artab Liquid Paraffin Ħafif
English: Intramammary emulsion
Maltese: Emulsjoni intramammarja
English: Meat: 42 days.
Maltese: 42 jum.
English: Intramammary suspension
Maltese: Suspensjoni intramammarja
English: Amoxicillin (as amoxicillin trihydrate):
Maltese: Amoxicillin (bħala amoxicillin trihydrate):
English: Do not use in cases associated with Pseudomonas.
Maltese: Tużax f'każijiet assoċċjati ma' Pseudomonas.
English: Milk:
Maltese: Billi:
English: Amoxicillin trihydrate equivalent to amoxicillin
Maltese: Amoxicillin trihydrate ekwivalenti għal amoxicillin
English: This combination is effective against -lactamase producing organisms.
Maltese: Din il-kombinazzjoni hija effettiva kontra organiżmi li jipproduċu il--lactamase.
English: Clavulanic acid (as potassium clavulanate):
Maltese: Clavulanic acid (bħala potassium clavulanate):
English: • Posology;
Maltese: • Il-pożoloġija;
English: Clavulanic acid inactivates -lactamases.
Maltese: Clavulanic acid jinattiva il--lactamases.
English: Harmonisation of the posology
Maltese: Armonizzazzjoni tal-pożoloġija
English: Potassium clavulanate equivalent to clavulanic acid
Maltese: Potassium clavulanate ekwivalenti għal clavulanic acid
English: No immune modulating effects of prednisolone were observed.
Maltese: Ma kienu osservati l-ebda effetti immuni modulatorji ta' prednisolone.
English: Low density polyethylene syringes packed in cartons containing 3, 12, 24 or 300 syringes.
Maltese: Siringi tal-low density polyethylene ippakkjati f'kaxxi tal-kartun li fihom 3, 12, 24 jew 300 siringa.
English: Cattle Edible tissues: 4 days
Maltese: Partijiet li jittieklu: 4 ijiem
English: • Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis);
Maltese: • Streptococci (inklużi S. agalactiae, S. dysgalactiae u S. uberis);
English: ROUTE(S) OF ADMINISTRATION Intramammary use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Synulox Lactating Cows and associated names and differences between the summary of product characteristics (SPC) of the product as authorised in the Member States, the issue was referred on 26 March 2010 by Belgium and Denmark to the CVMP under Article 34(1) of Directive 2001/82/EC.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri dwar l-awtorizzazzjoni ta' Synulox Lactating Cows u l-ismijiet assoċjati u d-differenzi bejn is-sommarju tal-karatteristiċi talprodott (SPC) kif awtorizzati fl-Istati Membri, fis-26 ta' Marzu 2010, il-Belġju u d-Danimarka rriferew ilkwistjoni lis-CVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE.
English: According to the provided pharmacodynamic data, the claimed pathogens are sensitive to the clavulanic acid / amoxicillin combination.
Maltese: Skont id-dejta farmakodinamika pprovduta, il-patoġeni identifikati huma sensittivi għall-kombinazzjoni ta' clavulanic acid / amoxicillin.
English: • Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis)
Maltese: • Streptococci (inklużi S. agalactiae, S. dysgalactiae u S. uberis)
English: The combination of amoxicillin and clavulanic acid has a broad spectrum antimicrobial activity including -lactamase producing organisms.
Maltese: Il-kombinazzjoni ta' amoxicillin u clavulanic acid għandha attività antimikrobjali bi spettru wiesa' li tinkludi organiżmi li jipproduċu -lactamase.
English: Kent CT13 9NJ United Kingdom
Maltese: Kent CT13 9NJ Renju Unit
English: Milk: 14 days.
Maltese: Ħalib: 14-il jum.
English: Analytical determinations of the marker residues were carried out by high-performance liquid chromatography.
Maltese: Determinazzjonijiet analitiċi tar-residwi markaturi saru permezz ta' kromatografija likwida ta' prestazzjoni għolja.
English: The comparator product was authorised for similar indications (Staphylococci, Streptococci, Escherichia coli), but has a different composition (penethamate, dihydrostreptomycin, framycetin and prednisolone) and a different interval of administration (24 hours for the comparator instead of 12
Maltese: Il-prodott komparatur kien awtorizzat għal indikazzjonijiet simili (Staphylococci, Streptococci, Escherichia coli), iżda b'kompożizzjoni differenti (penethamate, dihydrostreptomycin, framycetin u prednisolone) u b'intervall differenti ta' għoti (24 siegħa għall-komparatur minflok 12-il siegħa għal Synulox Lactating Cow).
English: It is presented in disposable intramammary syringes containing 50 mg clavulanic acid as potassium clavulanate; 200 mg amoxicillin as amoxicillin trihydrate and 10 mg prednisolone in 3 g suspension.
Maltese: Huwa ppreżentat f'siringi intramammarji li jintremew wara l-użu li fihom 50 mg clavulanic acid bħala potassium clavulanate; 200 mg amoxicillin bħala amoxicillin trihydrate u 10 mg prednisolone f'sospensjoni ta' 3 g.
English: There is little evidence of a real increase in amoxycillin/clavulanic acid resistance among the mastitic E. coli isolated in a number of European countries.
Maltese: Hemm ftit evidenza li turi żieda reali ta' reżistenza għal amoxycillin/clavulanic acid fost l-E. coli mastitiku iżolat f'numru ta' pajjiżi Ewropej.
English: Pharmacological properties: “Prednisolone is a glucocorticoid with anti-inflammatory properties.
Maltese: Karatteristiċi farmakoloġiċi: “Prednisolone huwa glukokortikojde b'karatteristiċi anti-infjammatorji.
English: Cattle Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment.
Maltese: Laħam: 7 ijiem Ħalib (baqar li jinħalbu darbtejn kuljum): 60 siegħa (i.e. fil-5 ħalba) wara l-aħħar trattament.
English: • Withdrawal periods.
Maltese: • Il-perjodi ta' irtirar.
English: Cattle Meat: 6 days Milk: 5 days
Maltese: Laħam: 6 ijiem Ħalib: 5 ijiem
English: For a full list of excipients see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti ara s-sezzjoni 6.1.
English: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Gram negative bacteria.
Maltese: Klinikament u batterjoloġikament Synulox Lactating Cow ma kienx inferjuri għall-komparatur fl-effikaċja kontra Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis u l-batterji Gram negattivi.
English: Cattle Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU:
Maltese: Laħam: 7 ijiem Ħalib: 60 siegħa F'kombinazzjoni ma' SYNULOX RTU:
English: Cattle Meat : 4 days Milk : 108 hours
Maltese: Laħam: 4 ijiem Ħalib: 108 siegħat
English: 200 mg
Maltese: 72 siegħa
English: The product is presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone in 3 g suspension.
Maltese: Il-prodott huwa ppreżentat f'siringi intramammarji li jintremew wara l-użu li fihom 200 mg amoxicillin bħala amoxicillin trihydrate, 50 mg clavulanic acid bħala potassium clavulanate u 10 mg prednisolone f'sospensjoni ta' 3 g.
English: After intramammary infusion, prednisolone can lead to a reduction in the local signs of inflammation (swelling and subsequent size of the infected quarter)” to be replaced with “Prednisolone is an anti-inflammatory corticosteroid.”.
Maltese: Wara infużjoni intramammarja , prednisolone jista' jwassal għal tnaqqis fis-sinjali lokali ta' infjammazzjoni (nefħa u daqs sussegwenti tar-ribbi nfettat)” għandha tiġi sostitwita bi “Prednisolone huwa kortikosterojde anti-infjammatorju.”.
English: Milk: 60 hours In combination with SYNULOX RTU:
Maltese: Ħalib: 60 siegħa F'kombinazzjoni ma' SYNULOX RTU:
English: • Staphylococci (including β-lactamase producing strains);
Maltese: • Staphylococci (inklużi razez li jipproduċu β-lactamase);
English: Romania Pfizer Animal Health MA EEIG
Maltese: Rumanija Pfizer Animal Health MA EEIG
English: Cattle Meat: 7 days Milk: 84 hours (7 milkings)
Maltese: Laħam: 7 ijiem Ħalib: 84 siegħa (7 ħalbiet)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Amoxicillin
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: Lithuania Pfizer Animal Health MA EEIG
Maltese: Litwanja Pfizer Animal Health MA EEIG
English: 4.1 Target species
Maltese: 4.3 Kontra indikazzjonijiet
English: A pharmacokinetic study demonstrated that prednisolone does not have a prolonged residence time in the milk/udder (about 8-10 hours post infusion, levels of prednisolone were less than 1µg/ml).
Maltese: Studju farmakokinetiku wera li prednisolone ma għandux ħin ta' residenza fit-tul fil-ħalib /fil-beżżula (madwar 8-10 sigħat wara l-infużjoni, il-livelli ta' prednisolone kienu inqas minn 1µg/ml).
English: In a Streptococcus uberis challenge, a single administration of the product reduced the udder swelling 4 and 6 hours post treatment, but no significant action was seen on the cellular response.
Maltese: Fi sfida bi Streptococcus uberis, għotja waħda tal-prodott naqqset in-nefħa fil-beżżula wara 4 u 6 sigħat wara l-kura, iżda ma dehret l-ebda azzjoni sinifikanti fir-rispons ċellulari.
English: Pharmacokinetic studies, performed with the finished product revealed individual concentrations of amoxicillin in milk above the MIC90 (2 µg/ml) for Staphylococcus aureus until 12 hours after the last infusion.
Maltese: Studji farmakokinetiċi, li saru bil-prodott lest urew konċentrazzjonijiet individwali ta' amoxicillin fil-ħalib ta' aktar mill-MIC90 (2 µg/ml) għal Staphylococcus aureus sa 12-il siegħa wara l-aħħar infużjoni.
English: No statistical difference was shown clinically and bacteriologically between both products.
Maltese: Klinikament u batterjoloġikament ma ntweriet l-ebda differenza statistika bejn iż-żewġ prodotti.
English: • Staphylococci (including β-lactamase producing strains)
Maltese: • Staphylococci (inklużi razez li jipproduċu β-lactamase)
English: Cattle Meat: 3 days Milk: 72 hours
Maltese: Laħam: 3 ijiem Ħalib: 72 siegħa
English: PHARMACEUTICAL FORM Intramammary suspension.
Maltese: Suspensjoni intramammarja.
English: Prednisolone administered before Escherichia coli endotoxin challenge may reduce the quarter size at some time points within 8 hours.
Maltese: Prednisolone mgħoti qabel l-isfida bl-endotossin Escherichia coli jista' jnaqqas id-daqs tar-ribbi f'ċerti punti fiż-żmien sa 8 sigħat wara.
English: Meat and offal: 7 days
Maltese: Laħam u Ġewwieni: 7 ijiem
English: • Escherichia coli (including β-lactamase producing strains).
Maltese: • Escherichia coli (inklużi razez li jipproduċu β-lactamase).
English: In the first study performed in 8 lactating dairy cows, amoxicillin was the limiting active substance to determine the withdrawal period which, according to these data, should be set at 7 milkings (84 hours).
Maltese: Fl-ewwel studju li sar fuq 8 baqar tal-ħalib li kienu qegħdin jreddgħu, amoxicillin kien is-sustanza attiva ta' limitu li tiddetermina l-perjodu ta' irtirar li, skont din id-dejta, għandu jiġi stabbilit għal 7 taħlibiet (84 siegħa).
English: Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains)
Maltese: Staphylococci (inklużi razez li jipproduċu -lactamase) Streptococci (inklużi S.agalactiae, S.dysgalactiae u S.uberis) Escherichia coli (inklużi razez li jipproduċu -lactamase)”
English: One syringe (3 g) contains:
Maltese: Siringa waħda (3 g) fiha:
English: Values were below the maximum residue limits from the 5th milking and the half-life was estimated to be less than 12 hours.
Maltese: Il-valuri kienu taħt il-limiti massimi ta' residwi mill-ħames taħliba u l-half-life kienet stmata li hija ta' anqas minn 12-il siegħa.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, withdrawal period, marketing authorisation holders in the member states
Maltese: Lista ta' ismijiet, għamla farmaċewtika, saħħa tal-prodotti mediċinali veterinarji, speċi, perjodu ta' tiżmim, sidien talawtoriżżazzjoni tal-kummerċ
English: None known.
Maltese: Saħħa
English: Cattle Meat: 7 days Milk: 4 days
Maltese: Laħam: 7 ijiem Ħalib: 4 ijiem
English: • In another study the efficacy of Synulox Lactating Cow for the treatment of clinical mastitis in the lactating dairy cow was compared with another veterinary medicinal product authorised in France.
Maltese: • Fi studju ieħor l-effikaċja ta' Synulox Lactating Cow għall-kura tal-mastite klinika fil-baqar tal-ħalib tat-treddigħ tqabblet ma' prodott mediċinali veterinarju ieħor awtorizzat fi Franza.
English: Benefit-risk assessment
Maltese: 3. Evalwazzjoni tal-benefiċċju-riskju
English: Amoxicillin is a broad spectrum bactericidal -lactam antibiotic.
Maltese: Amoxicillin huwa antibijotiku bi spettru wiesgħa u b'effett batteriċida tal-grupp -lactam.
English: For Escherichia coli MIC90 (16 µg/ml), individual milk levels in amoxicillin were above the MIC90 for the period covering the first 2 infusions.
Maltese: Għal Escherichia coli l-MIC90 (16 µg/ml), il-livelli individwali ta' amoxicillin fil-ħalib kienu aktar mill-MIC90 għal perjodu li jkopri l-ewwel 2 infużjonijiet.
English: Whereas:
Maltese: Laħam:
English: Pale cream/buff coloured oily suspension.
Maltese: Suspensjoni żejtnija ta' lewn il-krema ċara.
English: While a withdrawal period of 3 days could have been derived from the dataset, a withdrawal time of 7 days was recommended by the marketing authorisation holders.
Maltese: Filwaqt li perjodu ta' irtirar ta' 3 ijiem seta' ġie dderivat mid-dataset, il-perjodu ta' irtirar ta' 7 ijiem kien irrakkomandat mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Escherichia coli (including -lactamase producing strains)
Maltese: Escherichia coli (inklużi dawk l-istrejns li jipproduċu il- -lactamase)
English: Notwithstanding the conclusions on the efficacy of prednisolone, the combination was deemed efficacious against the claimed pathogens.
Maltese: Minkejja l-konklużjonijiet dwar l-effikaċja ta' prednisolone, il-kombinazzjoni kienet meqjusa bħala effikaċi kontra l-patoġeni identifikati.
English: Milk: 2 days
Maltese: Ħalib: 3 ijiem
English: In combination with SYNULOX RTU:
Maltese: F'kombinazzjoni ma' SYNULOX RTU:
English: “In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required.
Maltese: “F'każijiet ta' infezzjonijiet ikkawżati minn Staphylococcus aureus, jista' jkun meħtieġ kors itwal ta' terapija antibijotika.
English: The benefit of prednisolone is considered as indirect and is expected to be of short term.
Maltese: Il-benefiċċju ta' prednisolone huwa kkunsidrat bħala wieħed indirett u huwa mistenni li jkun ta' żmien qasir.
English: After the third infusion, the MIC90 of Escherichia coli was covered well for 10 hours and the levels were partially acceptable at 12 hours.
Maltese: Wara t-tielet infużjoni, il-MIC90 ta' Escherichia coli kien kopert sew għal 10 sigħat u l-livelli kienu parzjalment aċċettabbli fit-12-il siegħa.
English: Two clinical trials have been provided for Synulox Lactating Cow and associated names:
Maltese: Ġew ipprovduti żewġ provi kliniċi għal Synulox Lactating Cow u l-ismijiet assoċjati:
English: Experimental studies have been provided to support this statement.
Maltese: Ġew ipprovduti studji sperimentali biex jappoġġaw din id-dikjarazzjoni.
English: Therefore overall treatment length must be at the veterinarian's discretion but should be long enough to ensure complete resolution of intramammary infection.
Maltese: Għalhekk it-tul totali tat-trattament għandu jkun fid-diskrezzjoni tal-veterinarju imma għandu jkun twil biżżejjed biex ikun żgurat li l-infezzjoni mammarja titlaq kompletament.
English: While these experimental studies showed a positive effect of prednisolone on udder inflammation at some time-points following treatment, there were statistical deficiencies (small numbers of cows included, no grouped statistical analyses of sets of data) that meant that conclusions could not be drawn on the significance of the observed effects.
Maltese: Filwaqt li dawn l-istudji sperimentali wrew effett pożittiv ta' prednisolone fuq l-infjammazzjoni talbeżżula f'ċerti punti fiż-żmien wara l-kura, kien hemm defiċjenzi statistiċi (kienu nklużi numru żgħir ta' baqar, l-ebda analiżi statistika ta' settijiet ta' dejta) li jfissru li ma setgħux jinġibdu konklużjonijiet dwar is-sinifikat tal-effetti osservati.
English: The product is intended for the treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens:
Maltese: Il-prodott huwa maħsub għall-kura tal-mastite klinika bovina fil-baqar li qegħdin ireddgħu, inklużi każijiet ta' infezzjonijiet assoċjati mal-patoġeni segwenti:
English: Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Maltese: Renju Unit Pfizer Ltd Ramsgate Road Sandwich
English: While the clinical added value of prednisolone in Synulox Lactating Cow remains questionable, no risk arising from its use has been identified from clinical trials and pharmacovigilance.
Maltese: Filwaqt li l-valur kliniku miżjud ta' prednisolone f'Synulox Lactating Cow jibqa' dibattibbli, ma ġie identifikat l-ebda riskju mill-provi kliniċi u mill-farmakoviġilanza.
English: Added value of prednisolone in the combination The current SPC indicates that prednisolone has an anti-inflammatory action which helps to reduce the potentially destructive swelling and inflammation associated with mastitis, without affecting the white cell response to infection.
Maltese: L-SPC attwali jindika li prednisolone għandu azzjoni anti-infjammatorja li tgħin biex tnaqqas in-nefħa u l-infjammazzjoni potenzjalment distruttivi assoċjati mal-mastite, mingħajr ma taffettwa r-rispons taċċelloli bojod għall-infezzjoni.
English: EXP
Maltese: Awstrija
English: The CVMP was asked to address the following specific points:
Maltese: Is-CVMP intalab jindirizza l-punti speċifiċi li ġejjin:
English: Synulox Lactating Cow and associated names is a pale cream/buff coloured oily suspension containing amoxicillin, clavulanic acid and prednisolone in a base designed to disperse rapidly in milk.
Maltese: Synulox Lactating Cow u l-ismijiet assoċjati huwa sospensjoni żejtnija ta' lewn krema ċar/isfar skur li fiha amoxicillin, clavulanic acid u prednisolone f'bażi ddisinjata biex tinfirex malajr fil-ħalib.