FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint, change from baseline in serum potassium to the end of the 28-day treatment period, was significantly lower (p<0.001) in the patiromer group (LS mean [SEM]: −0.
Maltese: Il-punt aħħari tal-effikaċja primarja, il-bidla mil-linja bażi tal-potassium fis-serum sal-aħħar talperjodu tal-kura ta' 28 jum, kien aktar baxx b'mod sinifikanti ((p < 0.001) fil-grupp ta' patiromer (medja ta' LS [SEM]:
English: EU/1/17/1179/009 90 sachets
Maltese: EU/1/17/1179/009 90 qartas
English: Uncommon, may affect up to 1 in 100 people: nausea vomiting
Maltese: Mhux komuni, jistgħu jaffettwaw sa 1 minn kull 100 persuna:
English: EU/1/17/1179/003 90 sachets
Maltese: EU/1/17/1179/003 90 qartas
English: EXP
Maltese: Dardir
English: Due to the insolubility and nonabsorptive characteristics of this medicinal product, many classical pharmacokinetic studies cannot be carried out.
Maltese: Minħabba l-karatteristiċi ta' insolubbilità u mhux assorbenti ta' dan il-prodott mediċinali, ħafna studji farmakokinetiċi klassiċi ma jistgħux jitwettqu.
English: EU/1/17/1179/005 60 sachets
Maltese: EU/1/17/1179/005 60 qartas
English: In Part B, 107 patients with a Part A baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L and whose serum potassium was in the target range (3.8 mEq/L to <5.1 mEq/L) at Part A Week 4 and still receiving RAAS inhibitor treatment were randomised to continue patiromer or to receive placebo for 8 weeks to evaluate the effect of withdrawing patiromer on serum potassium.
Maltese: F'Parti B, 107 pazjent b'potassium fis-serum ta' 5.5 mEq/L sa < 6.5 mEq/L fil-linja bażi ta' Parti A, u li l-potassium fis-serum tagħhom kien fil-medda fil-mira (3.8 mEq/L sa < 5.1 mEq/L) f'Parti A Ġimgħa 4, u kienu għadhom qed jirċievu kura b'inibitur ta' RAAS, intgħażlu b'mod każwali biex ikomplu patiromer jew biex jirċievu plaċebo għal 8 ġimgħat, biex jiġi evalwat l-effett tat-twaqqif ta' patiromer fuq il-potassium fis-serum.
English: EU/1/17/1179/002 60 sachets
Maltese: EU/1/17/1179/002 60 qartas
English: More placebo patients (60% [95% CI: 47%, 74%]) developed a serum potassium ≥5.5 mEq/L at any time during
Maltese: Aktar pazjenti fuq il-plaċebo (60% [95% CI: 47%, 74%]) żviluppaw potassium fisserum ta' ≥ 5.5 mEq/L fi kwalunkwe ħin matul Parti B milli minn pazjenti fuq patiromer (15% [95% CI: 6%, 24%]), p < 0.001.
English: Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin.
Maltese: L-għoti fl-istess ħin ta' patiromer wera bijodisponibilità mnaqqsa ta' ciprofloxacin, levothyroxine u metformin.
English: • Drink the mixture within 1 hour after preparation.
Maltese: • Ixrob it-taħlita fi żmien siegħa wara l-preparazzjoni.
English: PHARMACEUTICAL FORM Powder for oral suspension.
Maltese: Trab għal suspensjoni orali
English: In Part B, serum potassium in patients on placebo increased significantly relative to patients who remained on patiromer (p<0.001).
Maltese: F'Parti B, il-potassium fis-serum żdied b'mod sinifikanti f'pazjenti fuq il-plaċebo meta mqabbel ma' pazjenti li baqgħu fuq patiromer (p < 0.001).
English: The safety and efficacy of Veltassa in children aged under 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Veltassa fi tfal li għandhom inqas minn 18-il sena għandhom ma ġewx determinati s'issa.
English: Veltassa contains calcium as part of the counterion complex.
Maltese: Veltassa fih il-calcium bħala parti mill-kumpless counterion.
English: In radiolabeled studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the faeces.
Maltese: Fl-istudji radjutikkettati fil-firien u l-klieb, patiromer ma ġiex assorbit b'mod sistematiku, u tneħħa flippurgar.
English: Discontinuing patiromer
Maltese: Twaqqif ta' patiromer
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/004 30 sachets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1179/004 30 qartas
English: Adverse reactions are listed below by system organ class and by frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi u skont ilfrekwenza.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/001 30 sachets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1179/001 30 qartas
English: The European Medicines Agency has deferred the obligation to submit the results of studies with patiromer in one or more subsets of the paediatric population in the treatment of hyperkalaemia (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b' patiromer f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura ta' iperkalemija (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1179/007 30 sachets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1179/007 30 qartas
English: Gastrointestinal disorder reactions were generally mild to moderate in nature, did not appear to be dose related, generally resolved spontaneously or with treatment, and none were reported as serious.
Maltese: Reazzjonijiet ta' disturbi gastrointestinali kienu ġeneralment ħfief sa moderati fin-natura tagħhom, ma dehrux li kienu relatati mad-doża, ġeneralment fiequ spontanjament jew bil-kura, u l-ebda waħda ma ġiet irrappurtata bħala serja.
English: Serum potassium at the end of treatment, the change from baseline in serum potassium, and the mean dose of patiromer were similar between groups.
Maltese: Il-potassium fis-serum fit-tmiem tal-kura, il-bidla mil-linja bażi fil-potassium fis-serum, u d-doża medja ta' patiromer kienu simili bejn il-gruppi.
English: Calcium is partially released some of which may be absorbed (see section 5.1).
Maltese: Il-calcium jintreħa parzjalment, u xi ftit minnu jista' jiġi adsorbit (ara sezzjoni 5.1).
English: Nausea Vomiting
Maltese: FIS-SUQ
English: The recommended starting dose is 8.4 g patiromer once daily.
Maltese: Id-doża rakkomandata hija ta' 8.4 g patiromer darba kuljum.
English: Package size blister (OPA/Al/PVC - Al), calendar
Maltese: 14-il pillola folja (OPA/Al/PVC - Al), kalendarja
English: 28x1 tablets l t o r
Maltese: 28x1 pillola t x
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets (multipack)
Maltese: Daqs tal-pakkett flixkun (HDPE) 30 pillola flixkun (HDPE) 90 (3 x 30) pillola (pakkett multiplu)
English: MA (EU) Numbers Invented name
Maltese: Numri tal-MA (EU) Isem ivvintat Qawwa Għamla farmaċewtika
English: Intravenous use vial (glass)
Maltese: Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: The absolute bioavailability was 74 %.
Maltese: Il-bijodisponibilità assoluta kienet ta' 74%.
English: EU/2/13/159/001 EU/2/13/159/002 EU/2/13/159/003 EU/2/13/159/004 EU/2/13/159/005 EU/2/13/159/006 EU/2/13/159/007 EU/2/13/159/008 EU/2/13/159/009 EU/2/13/159/010 EU/2/13/159/011 EU/2/13/159/012 EU/2/13/159/013 EU/2/13/159/014 EU/2/13/159/015 EU/2/13/159/016
Maltese: EU/2/13/159/011 EU/2/13/159/012 EU/2/13/159/013 EU/2/13/159/014
English: Date of first authorisation: 11/02/2014 Date of last renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 11/02/2014
English: Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus).
Maltese: Kura ta' infestazzjonijiet b'qurdien fil-klieb (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus).
English: Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Maltese: Afoxolaner huwa attiv kontra l-briegħed adulti kif ukoll speċi differenti ta' qurdien bħal Dermacentor reticulatus u D. variabilis, Ixodes ricinus,u I. Scapularis, Rhipicephalus sanguineus, Amblyomma americanum, u Haemaphysalis longicornis.
English: - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: Detailed information on this veterinary medicinal 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 tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu).
English: NexGard 11 mg dogs 2-4 kg NexGard 28 mg dogs >4-10 kg NexGard 68 mg dogs >10-25 kg NexGard 136 mg dogs >25-50 kg afoxolaner
Maltese: NexGard 11 mg klieb 2 - 4 kg NexGard 28 mg klieb >4 - 10 kg NexGard 68 mg klieb >10 - 25 kg NexGard 136 mg klieb >25 - 50 kg afoxolaner
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru reazzjoni(jiet) mhux mixtieqa
English: NexGard is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, and Haemaphysalis longicornis.
Maltese: NexGard huwa attiv kontra l-briegħed adulti kif ukoll speċi differenti ta' qurdien bħal Dermacentor reticulatus u D. variabilis, Ixodes ricinus, Ixodes hexagonus u I.
English: No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
Maltese: L-ebda effetti mhux mixtieqa ma ġew osservati fi ġriewi f'saħħithom tal-Beagle 'l fuq minn 8 ġimgħat meta ngħataw id-doża massima multiplikata għal 5 darbiet ripetuta 6 darbiet f'intervalli ta' 2 sa 4
English: CLINICAL PARTICULARS 4.1 Target species
Maltese: 4.5 Prekawzjonijiet Speċjali għal-Użu
English: NexGard 11 mg chewable tablets for dogs (2-4 kg) NexGard 28 mg chewable tablets for dogs (>4-10 kg) NexGard 68 mg chewable tablets for dogs (>10-25 kg) NexGard 136 mg chewable tablets for dogs (>25-50 kg) afoxolaner
Maltese: NexGard 11 mg pilloli li jintmagħdu għal klieb (2−4 kg) NexGard 28 mg pilloli li jintmagħdu għal klieb (> 4−10 kg) NexGard 68 mg pilloli li jintmagħdu għal klieb (> 10−25 kg) NexGard 136 mg pilloli li jintmagħdu għal klieb (> 25−50 kg)
English: − common (more than 1 but less than 10 animals in 100 animals treated)
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat)
English: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg
Maltese: NexGard 11 mg pilloli li jintmagħdu għal klieb 2−4 kg NexGard 28 mg pilloli li jintmagħdu għal klieb > 4−10 kg NexGard 68 mg pilloli li jintmagħdu għal klieb > 10−25 kg NexGard 136 mg pilloli li jintmagħdu għal klieb > 25−50 kg
English: NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs >4-10 kg NexGard 68 mg chewable tablets for dogs >10-25 kg NexGard 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Maltese: NexGard 11 mg pilloli li jintmagħdu għal-klieb 2−4 kg NexGard 28 mg pilloli li jintmagħdu għal-klieb >4−10 kg NexGard 68 mg pilloli li jintmagħdu għal-klieb >10−25 kg NexGard 136 mg pilloli li jintmagħdu għal-klieb >25−50 kg afoxolaner
English: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Maltese: Kaxxa fiha blister ta' 1, 3 jew 6 pilloli li jintmagħdu jew 15 il- blister ta' pilloli li jintmagħdu.
English: Królowej Marysieńki, 9 - 1
Maltese: Ul. Królowej Marysieńki, 9 - 1
English: ATCvet code: QI01AN01.
Maltese: Kodici ATĊ veterinarja QI01AN01.
English: 10,000 doses
Maltese: 10 000 doża
English: Innovation Center BioCity Nottingham Pennyfoot Street
Maltese: BioCity Nottingham Pennyfoot Street Nottingham
English: Brilliant Blue (E133) Red AC (E129) Vanillin
Maltese: Brilliant Blue (E133) Red AC (E129)
English: Evalon (vaccine)
Maltese: Evalon (vaċċin)
English: 7 rue Roland Garros, Batiment H 44700 - Orvault
Maltese: HIPRA FRANCE 7 rue Roland Garros, Batiment H 44700 - Orvault
English: la Selva 135
Maltese: Avda. la Selva 135
English: HIPRA EΛΛAΣ A.E. Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661 e-mail: greece@hipra.com
Maltese: Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661 e-mail: greece@hipra.com
English: HIPRA BENELUX NV Adequat Business Center Brusselsesteenweg 159 9090 Melle
Maltese: Adequat Business Center Brusselsesteenweg 159 9090 Melle
English: - 02 51 80 77 91 Fax - 02 51 8082 20 e-mail: france@hipra.com
Maltese: Tél. - 02 51 80 77 91 Fax - 02 51 8082 20 e-mail: france@hipra.com
English: HIPRAMUNE T, solvent for Evalon
Maltese: VETERINARJU HIPRAMUNE T, solvent għal Evalon
English: HIPRAMUNE T (solvent) - Brilliant blue (E 133) - Red AC (E 129) - Vanillin - Montanide IMS
Maltese: - Brilliant blue (E 133) - Red AC (E 129)
English: HIPRA BENELUX NV Adequat Business Center Brusselsesteenweg 159 9090 Melle e-mail: benelux@hipra.com
Maltese: Adequat Business Center Brusselsesteenweg 159 9090 Melle e-mail: benelux@hipra.com
English: 1,000 doses 5,000 doses
Maltese: 5 000 doża
English: To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Maltese: Għall-istimular tal-immunità attiva kontra koċċidjosi kkawżata minn Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix u Eimeria tenella.
English: Date of first authorisation: 18/04/2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 18/04/2016
English: La Selva 135, Amer, 17170 Gerona, Spain
Maltese: La Selva 135, Amer, 17170 Gerona, Spanja
English: 10 ml, 50 ml or 100 ml type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
Maltese: Kunjetti tal-ħġieġ bla kulur tat-tip I ta' 10 ml, 50 ml jew 100 ml li fihom 7 ml, 35 ml jew 70 ml ta' suspensjoni (1 000, 5 000 u 10 000 doża) magħluqin b'tappijiet tal-elastomer polimeriku tat-tip I u għotjien tal-aluminju.
English: BELGIUM e-mail: benelux@hipra.com
Maltese: e-mail: benelux@hipra.com
English: Eimeria acervulina, strain 003 .................................... 332 - 450 * Eimeria brunetti, strain 034 ........................................ 213 - 288 * Eimeria maxima, strain 013 ........................................ 196 - 265 * Eimeria necatrix, strain 033 ........................................ 340 - 460 * Eimeria tenella, strain 004 .......................................... 276 - 374 *
Maltese: 332 - 450* Eimeria brunetti, strejn 034 .......................................... 213 - 288* Eimeria maxima, strejn 013 .......................................... 196 - 265* Eimeria necatrix, strejn 033 ......................................... 340 - 460* Eimeria tenella, strejn 004 ........................................... 276 - 374*
English: Shake the solvent vial.
Maltese: Ilma Vaċċin Solvent
English: Excipients:
Maltese: Aġġuvant:
English: The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml/100 chicks, droplet size: 200-250 µm and working pressure: 2 to 3 bars).
Maltese: Il-metodu ta' amministrazzjoni huwa permezz ta' sprej oħxon billi jintuża strument xieraq (volum mogħti: 28 ml/100 fellus, daqs tal-qtajra: 200-250 µm u pressjoni ta' ħidma: 2 sa 3 bars).
English: Tel.: +34 972 430660 Fax: +34 972 430661 E-mail: hipra@hipra.com
Maltese: Fax: +34 972 430661
English: For active immunisation of chicks from 1 day of age to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Maltese: Għall-immunizzazzjoni attiva ta' flieles mill-età ta' jum sabiex jitnaqqsu s-sinjali kliniċi (dijarea), ilferiti intestinali u l-ammont ta' ooċisti ta' koċċidjosi kkawżata minn Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix uEimeria tenella.
English: la Selva, 135 17170 Amer (Girona) SPAIN
Maltese: Avda. la Selva, 135 17170 Amer (Girona)
English: Polypropylene (PP) vials containing 50 ml, 250 ml and 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Maltese: Kunjetti tal-polipropelin (PP) li fihom 50 ml, 250 ml u 500 ml ta' solvent magħluqin b'tappijiet talelastomer polimeriku tat-tip I u għotjien tal-aluminju.
English: Portela de Mafra e Fontaínha - Abrunheira 2665 - 191 Malveira e-mail: portugal@hipra.com
Maltese: 2665 - 191 Malveira e-mail: portugal@hipra.com
English: Batch {number}
Maltese: Jiskadi {xahar/sena}
English: Eimeria acervulina, strain 003 ......................................... 332-450 Eimeria brunetti, strain 034 ............................................. 213-288 Eimeria maxima, strain 013 ............................................. 196-265 Eimeria necatrix, strain 033 ............................................. 340-460 Eimeria tenella, strain 004 ............................................... 276-374
Maltese: Eimeria brunetti, strejn 034 .............................................. 213-288 Eimeria maxima, strejn 013 .............................................. 196-265 Eimeria necatrix, strejn 033 ............................................. 340-460
English: The active substances being principles of biological origin intended to produce active immunity are not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanzi attivi, minħabba li huma prinċipji ta' oriġini bijoloġika maħsubin sabiex jipproduċu immunità attiva ma humiex regolati bir-Regolament (KE) 470/2009.
English: Ul.
Maltese: C.
English: de Susqueda, Amer, 17170 Gerona, Spain
Maltese: Crta. de Susqueda, Amer, 17170 Gerona, Spanja Laboratorios Hipra, S.A.
English: Before starting the preparation, make certain to have a clean container available with sufficient capacity for preparing the diluted vaccine suspension.
Maltese: Qabel ma tibda l-preparazzjoni, ara li jkollok kontenitur nadif disponibbli b'kapaċità suffiċjenti biex tipprepara s-suspensjoni dilwita tal-vaċċin.
English: Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Maltese: Skeda tat-tilqim: Doża waħda tal-vaċċin (0.007 ml) mill-età ta' ġurnata.
English: NG1 1GF e-mail: ukandireland@hipra.com
Maltese: e-mail: ukandireland@hipra.com
English: Cardboard box with one vial of 5,000 doses (35 ml) and one vial with 250 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 5 000 doża (35 ml) u kunjett wieħed b'250 ml ta' solvent.
English: One vial of 5,000 doses and one vial with 250 ml of HIPRAMUNE T (solvent).
Maltese: Kunjett wieħed ta' 5 000 doża u kunjett wieħed b'250 ml ta' HIPRAMUNE T (solvent).
English: Cardboard box with one vial of 10,000 doses (70 ml) and one vial with 500 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 10 000 doża (70 ml) u kunjett wieħed b'500 ml ta' solvent.
English: One dose of vaccine (0.007 ml) from 1 day of age.
Maltese: U METODU TA' AMMINISTRAZZJONI Doża waħda tal-vaċċin (0.007 ml) mill-età ta' ġurnata.
English: Cardboard box with one vial of 1,000 doses (7 ml) and one vial with 50 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 1 000 doża (7 ml) u kunjett wieħed b'50 ml ta' solvent.
English: VACCINE
Maltese: VETERINARJU
English: Duration of immunity: 60 weeks post-vaccination in an environment that permits oocysts recycling.
Maltese: Tul tal-immunità: 60 ġimgħa wara t-tilqim f'ambjent li jippermetti r-riċiklaġġ tal-ooċisti.
English: One vial of 1,000 doses and one vial with 50 ml of HIPRAMUNE T (solvent).
Maltese: Kunjett wieħed ta' 1 000 doża u kunjett wieħed b'50 ml ta' HIPRAMUNE T (solvent).
English: EU/2/16/194/001 EU/2/16/194/002 EU/2/16/194/003
Maltese: EU/2/16/194/002
English: Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Maltese: Isem u indirizz tal-manifattur<i> responsabbli mill-ħruġ tal-lott. Laboratorios Hipra, S.A.
English: 02-954 - WARSZAWA e-mail: admin.polska@hipra.com
Maltese: e-mail: admin.polska@hipra.com
English: Alignment of the supplier's specifications for Foetal Bovine Serum (FBS) with the applicant's internal specifications for FBS, ensuring Ph. Eur.
Maltese: (FBS, Foetal Bovine Serum) mal-ispeċifikazzjonijiet interni tal-applikant għallFBS, li jiżgura l-konformità tal-Ph.
English: Evalon suspension and solvent for oral spray for chickens.
Maltese: VETERINARJU Evalon suspensjoni u solvent għal sprej mill-ħalq għat-tiġieġ.
English: One vial of 10,000 doses and one vial with 500 ml of HIPRAMUNE T (solvent).
Maltese: Kunjett wieħed ta' 10 000 doża u kunjett wieħed b'500 ml ta' HIPRAMUNE T (solvent).
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Doses
Maltese: KWANTITÀ
English: Each dose (0.007 ml) of undiluted vaccine contains:
Maltese: Kull doża (0.007 ml) tal-vaċċin mhux dilwit fiha:
English: Solvent
Maltese: Vanillin
English: Pharmacotherapeutic group: Immunological for Aves, live parasitic vaccines for domestic fowl.
Maltese: Immunoloġiku għat-Tjur, vaċċini parassitiċi ħajjin għat-tjur domestiċi.
English: No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-prodott mediċinali veterinarju immunoloġiku meta jintuża flimkien ma kwalunkwe prodott mediċinali veterinarju ieħor.
English: Coarse spray.
Maltese: Sprej oħxon.
English: Solvent: Dark brownish solution.
Maltese: Suspensjoni bajda mdardra: Solvent: Soluzzjoni ta' lewn kannella skur.
English: NG1 1GF - UNITED KINGDOM e-mail: ukandireland@hipra.com
Maltese: NG1 1GF - UNITED KINGDOM
English: Administration route:
Maltese: Ingredjenti oħra:
English: Alignment of the manufacturers' specifications for the plastic containers with the applicant's internal specifications for the plastic containers, ensuring Ph. Eur.
Maltese: L-allinjament tal-ispeċifikazzjonijiet tal-manifatturi għar-reċipjenti tal-plastik mal-ispeċifikazzjonijiet interni tal-applikant għar-reċipjenti tal-plastik, li jiżgura konformità tal-Ph.
English: LABORATORIOS HIPRA, S.A. Avda.
Maltese: Laboratorios Hipra, S.A. Avda. la Selva, 135
English: Dilute the vaccine with the corresponding volumes:
Maltese: Iddilwi l-vaċċin bil-volumi korrespondenti:
English: Vaccine
Maltese: KLINIKU
English: Onset of immunity: 3 weeks post-vaccination.
Maltese: Bidu tal-immunità: 3 ġimgħat wara t-tilqim.
English: Fill the reservoir of the spraying device with all the vaccine suspension prepared.
Maltese: Imla r-reservoir tal-istrument tal-isprej bis-suspensjoni kollha tal-vaċċin ippreparata.
English: MANUFACTURER'S BATCH NUMBER
Maltese: Polígono Industrial El Rieral