FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance consists of allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2).
Maltese: Is-sustanza attiva tikkonsisti minn ċelluli T alloġeniċi modifikati ġenetikament b'vettur retrovirali b'kowd għal forma mqassra tar-riċettur tal-fattur tat-tkabbir tan-nervituri uman ta' affinità baxxa (ΔLNGFR - human low affinity nerve growth factor receptor) u thymidine kinase tal-virus herpes simplex I (HSV-TK Mut2 - herpes simplex I virus thymidine kinase).
English: Non clinical safety data obtained in two different immunedeficient animal models for GvHD did not indicate special hazards for humans, but allowed only a very limited safety assessment.
Maltese: Dejta mhux klinika dwar is-sigurtà miksuba f'żewġ mudelli ta' annimali immunodefiċjenti differenti għal GvHD ma indikatx perikli speċjali għall-bnedmin, iżda ippermettiet biss valutazzjoni limitata ħafna tas-sigurtà.
English: The median interval time between the first and the subsequent infusions of Zalmoxis cells was 30 days.
Maltese: L-intervall medjan bejn l-ewwel infużjoni ta' ċelluli Zalmoxis u infużjonijiet sussegwenti kien 30 jum.
English: Only one 17-year-old male, affected by T lymphoblastic lymphoma, was treated in the TK007 trial with two infusions of Zalmoxis.
Maltese: Riżultati minn analiżi ta' par imqabbel li kien jinkludi 36 pazjent fuq Zalmoxis (22 mill-prova TK007
English: Zalmoxis is constituted of donor's T lymphocytes genetically modified to express the HSV-TK Mut2, as suicide gene.
Maltese: Zalmoxis huwa magħmula minn limfoċiti T tad-donatur modifikati ġenetikament biex ikollhom
English: • Conditional marketing authorisation
Maltese: • Awtorizzazzjoni ta' kummerċjalizzazzjoni kondizzjonali
English: Pyrexia
Maltese: ZALMOXIS
English: Zalmoxis is therefore not recommended for use in children and adolescent below 18 years.
Maltese: Zalmoxis għalhekk mhux rakkomandat għall-użu fi tfal u adolexxenti ta' inqas minn 18-il sena.
English: In the clinical study TK007, 30 patients with high-risk haematological malignancies undergoing HSCT received Zalmoxis monthly up to a maximum of four infusions.
Maltese: Fl-istudju kliniku TK007, 30 pazjent b'tumuri malinni ematoloġiċi ta' riskju għoli li kienu qed jirċievu HSCT rċevew Zalmoxis kull xahar sa massimu ta' erba' infużjonijiet.
English: In order to confirm the efficacy and safety of Zalmoxis as an adjunctive treatment in haploidentical haematopoietic stem-cell transplantation of adult patients with high-risk haematological malignancies, the MAH should submit the results of study TK008, a randomized phase III trial of haploidentical HCT with an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukaemia.
Maltese: In-natura u l-użu intenzjonat tal-prodott huma tali li studji konvenzjonali dwar il-farmakokinetika inkluż assorbiment, distribuzzjoni, metaboliżmu u eliminazzjoni mhumiex applikabbli. 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Ma twettqux studji konvenzjonali dwar l-effett tossiku, riskju ta' kanċer, mutaġeniċità u effett tossiku fuq is-sistema riproduttiva.
English: This allows the selective killing of dividing cells upon administration of the pro-drug GCV, which is enzymatically phosphorylated to an active triphosphate analogue by HSV-TK.
Maltese: Dan jippermetti l-qtil selettiv ta' ċelluli li qed jiddividu wara għoti talpro-droga GCV, li huwa fosforilat enzimatikament għal analogu triphosphate attiv permezz ta' HSV
English: It is important that you read the entire content of this procedure prior to administering Zalmoxis.
Maltese: F'xi każijiet, jista' jkun li ma tkunx tista' tirċievi infużjoni skedata ta' Zalmoxis.
English: • Zalmoxis has a shelf life of 18 months when stored in liquid nitrogen vapour.
Maltese: • Zalmoxis jibqa' tajjeb għal 18-il xahar meta jinħażen fi fwar ta' nitroġenu likwidu.
English: HOW TO STORE ZALMOXIS
Maltese: Tużax Zalmoxis:
English: In case of GvHD progression after 3 days of treatment with ganciclovir or valganciclovir alone, a standard immunosuppressive therapy has to be added.
Maltese: F'każ ta' progressjoni ta' GvHD wara 3 ijiem ta' trattament b'ganciclovir jew valganciclovir waħdu, għandha tiġi miżjuda terapija immunosoppressiva standard.
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni)
English: Symptoms of overdose are not known.
Maltese: Mhux magħrufa sintomi ta' doża eċċessiva.
English: Pregnancy
Maltese: KONDIZZJONALI
English: The recommended dose and schedule is 1 ± 0.2 x 107 cells/kg given as an intravenous infusion at a time interval of 21-49 days from transplantation, in the absence of spontaneous immune reconstitution and/or development of graft-versus-host disease (GvHD).
Maltese: Pożoloġija Id-doża rakkomandata u l-iskeda hija 1 ± 0.2 x 107 ċellula/kg mogħtija bħala infużjoni fil-vini f'intervall ta' ħin ta' 21-49 jum wara t-trapjant, fin-nuqqas ta' rikostituzzjoni immuni spontanja u/jew żvilupp ta' marda tat-trapjant kontra l-ospitant (GvHD - graft-versus-host disease) Infużjonijiet addizzjonali jingħataw f'intervalli ta' madwar xahar għal massimu ta' erba' darbiet, sakemm l-għadd ta' limfoċiti T fiċ-ċirkolazzjoni jkun daqs jew aktar minn 100 f'kull μL.
English: - Post-transplantation lymphoproliferative disorder (increase in the number of white blood cells in the blood after a transplantation) - Chronic graft-versus-host disease (a complication that can occur after a stem-cell or bone marrow transplantation in which the newly transplanted donor cells attack the patient's body) - Intestinal haemorrage (bleeding in the gut) - Hepatic failure (liver malfunction) - Febrile neutropenia (fever associated with reduction of the number of white blood cells) - Decreased haemoglobin (reduction of the number of red blood cells)
Maltese: - Tnaqqis fl-emoglobina (tnaqqis fl-għadd ta' ċelluli ħomor tad-demm) - Tnaqqis fl-għadd tal-plejtlits (tnaqqis fl-għadd ta' plejtlits fid-demm) - Bronkite (infezzjoni fil-pulmun) - Deni
English: The package is checked for the presence of any abnormality in the outer box and the label is checked for patient/donor correspondance.
Maltese: Il-pakkett huwa ċċekkjat għall-preżenza ta' kwalunkwe anormalità fil-kaxxa ta' barra u t-tikketta hija ċċekkjata li taqbel mal-pazjent/donatur.
English: Treatment should be discontinued in case of occurrence of any 3-4 grade event related to Zalmoxis administration or grade 2 adverse event not resolving in a grade 1 or less in the next 30 days.
Maltese: It-trattament għandu jitwaqqaf f'każ ta' kwalunkwe avveniment ta' grad 3-4 relatat mal-għoti ta' Zalmoxis jew avveniment avvers ta' grad 2 li ma jitjiebx għal grad 1 jew inqas fit-30 jum li jmiss.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment with Zalmoxis.
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċezzjoni effettiva waqt u sa 6 xhur wara t trattament b'Zalmoxis.
English: Zalmoxis is obtained by donor blood cells.
Maltese: Zalmoxis jinkiseb minn ċelluli tad-demm ta' donatur.
English: • Check that the patient identity matches the essential and unique patient information reported on the Zalmoxis bag and on the Certificate of Analysis.
Maltese: • Iċċekkja li l-identità tal-pazjent taqbel mal-informazzjoni essenzjali u unika tal-pazjent irrappurtata fuq il-borża ta' Zalmoxis u fuq iċ-Ċertifikat ta' Analiżi.
English: The use of Zalmoxis is not recommended for children and adolescents under the age of 18.
Maltese: L-użu ta Zalmoxis mhux rakkomandat għal tfal u adolexxenti taħt l-età ta' 18-il sena.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Maltese: KONDIZZJONALI Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tar
English: Each bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL.
Maltese: Kull borża fiha volum ta' 10-100 mL ta' dispersjoni ffriżata f'konċentrazzjoni ta' 5-20 x 106 ċellula/mL.
English: In this case treatment with Zalmoxis should be delayed until 24 hours after the end of the antiviral therapy.
Maltese: F'dan il-każ it-trattament b'Zalmoxis għandu jiġi ttardjata sa 24 siegħa wara t-tmiem tat-terapija antivirali.
English: Treatment plan consisted of the administration of genetically modified donor's T lymphocytes (ranging from 1 x 106 to 1 x 107 cells/kg body weight).
Maltese: (firxa minn 1 x 106 sa 1 x 107 ċellula/kg ta' piż tal-ġisem).
English: Immune reconstitution defined as circulating T lymphocytes ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Maltese: Rikostituzzjoni immuni definita bħala limfoċiti T fiċ-ċirkolazzjoni ta' ≥100 f'kull μL fil-jum tal-infużjoni ppjanata wara trapjant ta' HSCT aploidentiku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) The bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL
Maltese: Il-borża fiha volum ta' 10-100 mL ta dispersjoni iffriżata f'konċentrazzjoni ta' 5-20 x 106 ċellula/mL LISTA
English: Women of childbearing potential have to provide a negative pregnancy test (serum or urine) within 14 days prior to start the treatment.
Maltese: Nisa li jistgħu joħorġu tqal għandhom jipprovdu test tat-tqala negattiv (serum jew awrina) fi żmien 14-il ġurnata qabel ma' jinbeda t-trattament.
English: o The room requirements for Zalmoxis administration o Storage, transport and thawing of Zalmoxis bag o Surveillance of Zalmoxis efficacy (Immune reconstitution - IR)
Maltese: o Ħtiġijiet tal-kamra għall-għoti ta' Zalmoxis o Ħażna, trasport u kif il-borża ta' Zalmoxis titħalla tilħaq temperatura tal-kamra o Sorveljanza tal-effikaċja ta' Zalmoxis (Rikostituzzjoni immuni - IR [Immune reconstitution])
English: All signs and symptoms of grade 2 to 4 acute and extensive chronic GvHD fully resolved after a median treatment duration of GCV or VCV of 15 days.
Maltese: Is-sinjali u s sintomi kollha ta' GvHD akuta u kronika estensiva ta' grad 2 sa 4 għaddew għal kollox wara tul medjan ta' trattament b'GCV jew VCV ta' 15-il jum.
English: Shelf life after thawing: 2 hours
Maltese: Fuljett ta' tagħrif:
English: premature babies.
Maltese: prematuri.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 March 2017 EMA/188385/2017 EMEA/H/C/004100
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 ta' Marzu 2017 EMA/188385/2017 EMEA/H/C/004100
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate) EMA/188385/2017
Maltese: Irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Blectifor (ċitrat tal-kafeina) EMA/188385/2017
English: Blectifor is a medicine that contains the active substance caffeine citrate.
Maltese: Blectifor huwa mediċina li fiha s-sustanza attiva ċitrat tal-kafeina.
English: What is Blectifor?
Maltese: 'inhu Blectifor?
English: Further information on the orphan designation can be found here.
Maltese: -klassifikazzjoni orfni jista
English: On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.
Maltese: 2017, Viridian Pharma Ltd għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Blectifor, għall-prevenzjoni ta lażija bronkopulmonari.
English: The company presented data from the published scientific literature mainly on the use of caffeine citrate for the treatment of primary apnoea in premature babies; several articles also provided data on the development of bronchopulmonary dysplasia in these patients.
Maltese: Il-kumpanija ppreżentat data mil-letteratura xjentifika ppubblikata prinċipalment dwar l-użu taċ-ċitrat tal-kafeina għall-kura ta' apnea primarja fi trabi prematuri; diversi artikoli pprovdew ukoll data dwar liżvilupp ta' displażija bronkopulmonari f'dawn il-pazjenti.
English: What was Blectifor expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Blectifor?
English: The active substance in Blectifor, caffeine citrate, is a stimulant of the nervous system and is currently authorised in the EU as Peyona for the treatment of a breathing disorder called primary apnoea in
Maltese: -ċitrat tal-kafeina, hija stimulant tas-sistema nervuża u bħalissa hi awtorizzata fl-UE bħala Peyona għall-kura ta
English: Blectifor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2014 for the prevention of bronchopulmonary dysplasia.
Maltese: Blectifor kien ikklassifikat bħala "mediċina orfni" (mediċina li tintuża f
English: In these babies, the continuous high pressure and high concentration of the oxygen supplied through mechanical ventilation may cause inflammation and injury to the lungs and prevent normal development of the alveoli (air sacs in the lungs).
Maltese: 'dawn it-trabi, il-pressjoni għolja kontinwa u lkonċentrazzjoni għolja tal-ossiġnu fornut permezz tal-ventilazzjoni mekkanika jistgħu jikkawżaw infjammazzjoni u ħsara lill-pulmuni u jipprevjenu l-iżvilupp normali tal-alveoli (boroż tal-arja filpulmuni).
English: Furthermore, the proposed indication was not supported by the provided literature, and the target population was considered not sufficiently characterised.
Maltese: -indikazzjoni proposta ma kinitx appoġġjata bil-letteratura provduta u l-popolazzjoni fil-mira tqieset li mhijiex ikkaratterizzata b 'mod suffiċjenti.
English: In the prevention of bronchopulmonary dysplasia, caffeine citrate is expected to act mainly by stimulating the part of the brain that controls breathing, which is thought to help babies breathe on their own and reduce the time spent on mechanical ventilation.
Maltese: -ċitrat tal-kafeina hi mistennija taġixxi prinċipalment billi tistimula l-parti tal-moħħ li tikkontrolla n-nifs, li hi maħsuba li tgħin lit-trabi jieħdu nnifs waħedhom u tnaqqas il-ħin li jqattgħu fuq ventilazzjoni mekkanika.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that, based on the data submitted by the company, Blectifor could not have been approved for the prevention of bronchopulmonary dysplasia.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu ħafna tħassib u kien tal-opinjoni provviżorja li abbażi tad-data ppreżentata mill-kumpanija, Blectifor ma setax jiġi approvat għallprevenzjoni ta' displażija bronkopulmonari.
English: In addition, caffeine citrate may also have other effects in the lungs, such as reducing inflammation, which are expected to prevent the damage that leads to bronchopulmonary dysplasia.
Maltese: Barra minn hekk, iċ-ċitrat talkafeina jista' jkollha effetti oħrajn fil-pulmuni, bħal pereżempju t-tnaqqis ta' infjammazzjoni, li mistennija jipprevjenu d-dannu li jwassal għal displażija bronkopulmonari.
English: Questions and answers
Maltese: F
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate)
Maltese: Irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Blectifor (ċitrat tal-kafeina)
English: Blectifor was expected to be used to prevent bronchopulmonary dysplasia, a lung disease affecting premature babies who have been on prolonged mechanical ventilation (using a machine that supplies oxygen to support breathing).
Maltese: -pulmun li taffettwa lit-trabi prematuri li jkunu ilhom fuq ventilazzjoni mekkanika prolungata (bl-użu ta
English: EU/1/18/1350/001 Vantobra
Maltese: EU/1/18/1350/001
English: 170 mg Nebuliser solution Inhalation use ampoule (LDPE)
Maltese: Għal biex jinġibed mannifs ampulla (PE)
English: 56 ampoules + 1 administration device
Maltese: 56 ampulla x strument għallgħoti wieħed
English: Avoid introduction of contamination.
Maltese: Evita l-introduzzjoni ta'kontaminazzjoni.
English: Member State/EEA
Maltese: Membru/ EEA
English: Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton
Maltese: Renju Unit Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton
English: 3) the minimum efficacious titre is 4.0 TCID50
Maltese: 3) it-titri minimu effikaċi huwa ta' 4.0 TCID50
English: Intervet GmbH Siemensstrasse
Maltese: Awstrija Intervet GmbH Siemensstrasse 107
English: CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf
Maltese: Linja gwida tas-CVMP dwar ir-rekwiżiti għal għoti fl-istess ħin ta' prodotti mediċinali veterinarji immunoloġiċi (EMEA/CVMP/550/02-FINALI) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf
English: Rua Agualva dos Açores, n.º
Maltese: Intervet PortugalSaúde Animal, Lda Rua Agualva dos Açores, n.º 16,
English: CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
Maltese: Linja gwida tas-CVMP dwar ir-rekwiżiti tad-dejta bħala appoġġ għall-klejms tal-istabbilità waqt l-użu għal vaċċini veterinarji (EMEA/CVMP/IWP/250147/2008-KONSULTAZZJONI)http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
English: The marketing authorisation holder has demonstrated that there is no immunological interference when the vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq wera li ma kien hemm ebda interferenza immunoloġika meta l-vaċċini tħalltu u dan irriżulta fiżżamma tal-istess livell ta' effikaċja permezz tal-investigazzjoni ta' parametru ta' investigazzjoni wieħed, tnaqqis fil-viraemija (tnaqqis ta' 70-75% wara użu simultanju u tnaqqis ta' 72-75% wara użu ta' Porcilis PRRS waħdu).
English: Germany Intervet Deutschland GmbH
Maltese: Ġermanja Intervet Deutschland GmbH
English: Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae and dl--tocopherol acetate as adjuvant.
Maltese: Porcilis M Hyo huwa prodott mediċinali veterinarju immunoloġiku li fih Mycoplasma hyopneumoniae u dl-α-tocopherol acetate bħala sustanza aġġuntattiva.
English: 2) the apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Maltese: 2) il-waqa' apparenti tul siegħa mit-titre mar-rilaxx (6.4/6.2 TCID50) hija ta' 0.12/-0.02
English: Porcillis M.Hyo
Maltese: Porcilis M Hyo
English: 2.1 In-use shelf-life proposed after mixing the two products (Porcilis PRRS and Porcilis M Hyo)
Maltese: 2.1 Ħajja waqt l-użu proposta wara t-taħlita taż-żewġ prodotti (Porcilis PRRS u Porcilis M Hyo)
English: 25 doses
Maltese: 25 dożi
English: Citywest Road Dublin 24
Maltese: Magna Drive Magna Business Park Citywest Road Dublin 24
English: The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis M Hyo in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Intervet International BV, issottometta applikazzjoni ta' varjazzjoni ta' Tip II soġġetta għall-Proċedura ta' Rikonoxximent Reċiproku għall-Awtorizzazzjonijiet għat-Tqegħid fis-Suq tal-prodott mediċinali veterinarju Porcilis M Hyo fil-qafas tal-Artikolu 6 tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003.
English: A transient swelling/redness (max. diameter 5 cm) may occur at the injection site diminishing over a period of maximally 14 days.
Maltese: Nefħiet/ħmura temporanji (mass. 5cm dijametru) jistgħu jfeġġu fil-post tal-injezzjoni li tonqos fuq perjodu ta'massimu ta' 14 il-ġurnata.
English: 6.2 Incompatibilities Do not mix with any other veterinary medicinal product except with Porcilis PRRS.
Maltese: .2 Inkompatibilitajiet Tħallatx ma prodotti mediċinali veterinarji oħra minbarra ma Porcilis PRRS.
English: Unterschleißhei m
Maltese: PORCILIS M.
English: Nevertheless absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is not significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products.
Maltese: Madankollu, in-nuqqas ta' interferenza immunoloġika ma ġiex dedott iżda intwera b'mod ċar billi ġiet ipprovduta dejta ta' sfida tal-laboratorju li uriet li ma hemmx differenza sinifikanti fil-protezzjoni bejn annimali mlaqqma bil-prodotti mħallta u dawk imlaqqma bi prodotti singoli.
English: Benefit/Risk assessment
Maltese: 3. Valutazzjoni tal-Benefiċċju/Riskju
English: After opening: 3 hours.
Maltese: Wara li jinfetaħ: 3 siegħat.
English: The results indicated that there was a limited drop in the PRRS virus titre after mixing with Porcilis M Hyo (average drop after the claimed 1 hour in-use shelf life of 0.05 log).
Maltese: Irriżultati indikaw li kien hemm waqa' limitata fit-titre tal-virus tal-PRRS wara t-taħlita ma' Porcilis M Hyo (waqa' medja wara ħajja waqt l-użu ta' siegħa ta' 0.05 log).
English: 5831 AN
Maltese: 5831 AN Boxmeer The Netherlands
English: 0.02 (mean 0.05) which is within assay variability;
Maltese: (medja 0.05) li hija fi ħdan il-varjabbiltà tal-assaġġ;
English: After mixing with Porcilis PRRS: 1 hour (at room temperature)
Maltese: Wara li jitħallat mal- Porcilis PRRS: 1 siegħa (temperature tal-kamra)
English: CARBAJOSA DE LA SAGRADA
Maltese: CARBAJOSA DE LA SAGRADA 37188 SALAMANCA
English: The marketing authorisation holder considered that, based on the “Guideline on requirements for concurrent administration of immunological veterinary medicinal products*, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq qies li, abbażi tal-“Linja gwida dwar irrekwiżiti għal għoti fl-istess ħin ta' prodotti mediċinali veterinarji immunoloġiċi*, id-dejta dwar l-effikaċja tal-prodotti individwali, inkluż it-tul tal-immunità, tista' tiġi applikata għallużu fl-istess ħin tagħhom fin-nuqqas ta' interferenza immunoloġika.
English: 2.3 Potential impact on the efficacy parameter of duration of immunity due to an interference caused by mixing of the two products.
Maltese: 2.3 Impatt potenzjali fuq il-parametru tal-effikaċja tat-tul tal-immunità minħabba interferenza kkawżata bit-taħlita taż-żewġ prodotti.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS M HYO (SEE ANNEX I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' PORCILIS M HYO (ARA L-ANNESS I)
English: List of the names, pharmaceutical forms, strengths of the Veterinary medicinal product, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
Maltese: VETERINARJU, SPEĊJI TALANNIMALI, METODU TA'AMMINISTRAZZJONI, ŻMIEN TA' TIŻMIM, TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ MARKETING FL-ISTATI
English: Intervet Ireland Limited, Magna Drive Magna Business Park
Maltese: Intervet Ireland Limited,
English: Vaccination scheme:
Maltese: Skema tal-vaċċinazzjoni: