FrancophonIA/ELRC3.0 huggingface dataset:
English: Calcium and vitamin D levels should be monitored.
Maltese: Għandhom jiġu mmonitorjati l-livelli tal-kalċju u tal-vitamina D.
English: • Oral anticoagulants, due to a possible impact of corticosteroids on the metabolism of the oral anticoagulant and on coagulation factors, as well as the haemorrhagic risk (mucosa of the digestive tract, vascular fragility) of dexamethasone therapy itself at high doses or treatment periods above 10 days.
Maltese: • Antikoagulanti orali, minħabba l-impatt possibbli tal-kortikosterojdi fuq il-metaboliżmu talantikoagulant orali u fuq il-fatturi ta' koagulazzjoni, kif ukoll ir-riskju ta' emorraġija (mukuża talapparat diġestiv, fraġilità vaskulari) tat-terapija b'dexamethasone nnifisha f'dożi għoljin jew perjodi ta' kura ta' aktar minn 10 ijiem.
English: − Failure of the kidneys.
Maltese: Indeboliment tal-fejqan.
English: FN was associated with dose interruption in 3.7% of patients, and with dose reduction in 1.3% of patients, and with no treatment discontinuations.
Maltese: FN kienet assoċjata ma' interruzzjoni tad-doża f'3.7% tal-pazjenti, u ma' tnaqqis tad-doża f'1.3% tal-pazjenti, u ma' ebda twaqqif tal-kura.
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients).
Maltese: Episodji ta' newtropenija bid-deni ta' grad 4 kienu osservati b'mod mhux frekwenti (0.6% fil-pazjenti li ngħataw lenalidomide/dexamethasone meta mqabbel ma' 0.0% fil-pazjenti li ngħataw plaċebo/dexamethasone).
English: Parasite eradication must be successfully terminated before dexamethasone use (see section 4.4).
Maltese: Il-qerda tal-parassiti trid tkun intemmet b'suċċess qabel l-użu ta' dexamethasone (ara sezzjoni 4.4).
English: Neofordex is a high-dose glucocorticoid.
Maltese: X'inhu Neofordex u għalxiex jintuża 2.
English: Febrile neutropenia (FN) was experienced in 6.7% of patients who received Pom + LD-Dex, and in no patients who received HD-Dex.
Maltese: Newtropenija bid-deni (Febrile Neutropenia, FN) kienet esperjenzata f'6.7% tal-pazjenti li rċevew Pom + LD-Dex, u fl-ebda pazjent li rċieva
English: Uncommon: Dehydration, hypocalcaemia, hypomagnesemia; Not known: Glucose tolerance impaired, sodium retention, metabolic alkalosis.
Maltese: Indeboliment tat-tolleranza għall-glukożju, żamma tas-sodju, alkalożi metabolika.
English: Smoking has no influence on dexamethasone pharmacokinetics.
Maltese: Effetti ta' prodotti mediċinali oħra fuq dexamethasone
English: How to store Neofordex 6.
Maltese: Kif taħżen Neofordex 6.
English: Paediatric population There is no relevant use of Neofordex in the paediatric population in the indication multiple myeloma.
Maltese: Popolazzjoni pedjatrika Neofordex fil-popolazzjoni pedjatrika m'għandux użu rilevanti fl-indikazzjoni tal-majeloma multipla.
English: Magyarország Laboratoires CTRS Teл.
Maltese: Luxembourg/Luxemburg Laboratoires CTRS Tél/Tel:
English: Very common: Insomnia;
Maltese: Mhux komuni: Ipotirojdiżmu;
English: Glucocorticoid therapy may reduce the effect of anti-diabetic and antihypertensive treatment.
Maltese: It-terapija bil-glukokortikojdi tista' tnaqqas l-effett tal-kura kontra d-dijabete u kontra l-ipertensjoni.
English: There is a linear relationship between administered and bioavailable doses.
Maltese: Hemm relazzjoni lineari bejn id-dożi mogħtija u dawk bijodisponibbli.
English: • Praziquantel, due to the reduction of praziquantel plasma concentrations due to an increase of its hepatic metabolism by dexamethasone, with a risk of failure of treatment.
Maltese: • Praziquantel, minħabba t-tnaqqis fil-konċentrazzjonijiet ta' praziquantel fil-plażma minħabba żieda filmetaboliżmu epatiku tiegħu minn dexamethasone, b'riskju ta' falliment tal-kura.
English: Potassium supplementation should be given particularly if there is a risk of cardiac arrhythmia or concurrent hypokalaemic medicinal products.
Maltese: Għandha tingħata supplementazzjoni tal-potassju b'mod partikolari jekk ikun hemm ir-riskju ta' arritmija kardijaka jew prodotti mediċinali ipokalimiċi konkomitanti.
English: Ciclosporin may also increase the intracellular uptake of dexamethasone.
Maltese: Ciclosporin jista' jżid ukoll it-teħid intraċellulari ta' dexamethasone.
English: • Midazolam, due a reduction in midazolam plasma levels by CYP3A4 induction.
Maltese: • Midazolam minħabba tnaqqis qawwi fil-livelli ta' midazolam fil-plażma permezz ta' induzzjoni ta' CYP3A4.
English: Dexamethasone can suppress skin reaction to allergy testing.
Maltese: Dexamethasone jista' jrażżan l-ittestjar ta' reazzjoni tal-ġilda għal allerġija.
English: How to take Neofordex
Maltese: neofordex
English: In addition, convulsions have been reported with concurrent use of dexamethasone and ciclosporin.
Maltese: Barra minn hekk, kien hemm rapporti ta' konvulżjonijiet bl-użu konkomitanti ta' dexamethasone u ciclosporin.
English: The patient should continue anticoagulation therapy during the course of treatment with dexamethasone and thalidomide or its analogues.
Maltese: Il-pazjent għandu jkompli t-terapija kontra l-koagulazzjoni matul il-kura b'dexamethasone u thalidomide jew l-analogi tiegħu.
English: • Aminogluthetimide, due to a reduction of the efficacy of dexamethasone through an increase of its hepatic metabolism.
Maltese: • Aminogluthetimide, minħabba tnaqqis fl-effikaċja ta' dexamethasone permezz ta' żieda fil-metaboliżmu epatiku tiegħu.
English: The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients).
Maltese: Il-kombinazzjoni ta' lenalidomide ma' dexamethasone f'pazjenti li għandhom majeloma multipla li reġgħet tfaċċat jew li kienet refrattorja hija assoċjata ma' inċidenza ogħla ta' newtropenija ta' grad 4 (5.1% fil-pazjenti li ngħataw lenalidomide/dexamethasone meta mqabbel ma' 0.6% fil-pazjenti li ngħataw plaċebo/dexamethasone).
English: − Bacterial, viral or fungal infections, including pneumonia, shingles, infections of the nose, mouth, tonsils or throat, bronchitis, herpes, bladder infection;
Maltese: − Infezzjonijiet batteriċi, virali jew fungali, inklużi pulmonite, ħruq ta' Sant'Antnin, infezzjonijiet fl imnieħer, fil-ħalq, fit-tunsilli jew fil-gerżuma, bronkite, erpete, infezzjoni fil-bużżieqa tal-awrina;
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Maltese: Jekk il-pazjent jesperjenza xi avveniment tromboemboliku, il-kura għandha titwaqqaf u tinbeda terapija standard kontra l-koagulazzjoni.
English: Dexamethasone is similar to glucocorticoids which are naturally produced in the body.
Maltese: Dexamethasone huwa simili għall-glukokortikojdi li jiġu prodotti b'mod naturali fil-ġisem.
English: Very common: Muscular weakness, muscle cramps; Common: Myopathy, musculoskeletal pain, arthralgia, pain in extremity;
Maltese: Komuni ħafna: Dgħjufija fil-muskoli, bugħawwieġ fil-muskoli; Komuni: Mijopatija, uġigħ muskolu-skeletriku, artralġja, uġigħ flestremitajiet;
English: All were reported to be Grade 3 or 4.
Maltese: Kollha kienu rrapportati bħala ta' Grad 3 jew 4.
English: How to store Neofordex
Maltese: Mediċini oħra u Neofordex
English: Other possible side effects may be:
Maltese: Effetti sekondarji possibbli oħra jistgħu jkunu:
English: Neofordex contains lactose
Maltese: X'inhu Neofordex u gћal xiex jintuża
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta ta' tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: BLISTER
Maltese: Pożoloġija
English: Neofordex contains lactose, a sugar.
Maltese: Neofordex huwa glukokortikojd ta' doża għolja.
English: Concomitant administration of erythropoietic medicinal products may also increase thrombotic risk in these patients.
Maltese: L-għoti konkomitanti ta' prodotti mediċinali eritropojetiċi jistgħu wkoll iżidu r-riskju trombotiku f'dawn il-pazjenti.
English: Patients/carers should also be alert to possible psychiatric disturbances that may occur either during, or immediately after, dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Maltese: Ilpazjenti/dawk li jieħdu ħsiebhom għandhom ikunu inkoraġġiti jfittxu parir mediku jekk jiżviluppaw sintomi psikoloġiċi inkwetanti, speċjalment jekk ikun hemm suspett ta' burdata depressa jew ħsibijiet ta' suwiċidju.
English: Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma treated with the combination of dexamethasone with pomalidomide.
Maltese: Newtropenija kienet ir-reazzjoni avversa ematoloġika ta' Grad 3 jew 4 irrapportata l-iktar ta' spiss f'pazjenti b'majeloma multipla li reġgħet tfaċċat/refrattarja kkurati bit-taħlita ta' dexamethasone ma' pomalidomide.
English: − Increased need for diabetes medicine, salt imbalance, potassium loss due to low carbon dioxide levels (a condition called metabolic alkalosis);
Maltese: − Ħtieġa ikbar ta' mediċini għad-dijabete, żbilanċ fil-melħ, telf tal-potassju minħabba livelli baxxi tad dijossidu tal-karbonju (kondizzjoni msejħa alkalożi metabolika);
English: Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8).
Maltese: Il-pazjenti u/jew dawk li jieħdu ħsiebhom għandhom jiġu mwissija li jistgħu jseħħu reazzjonijiet avversi psikjatriċi potenzjalment severi bl-użu ta' sterojdi sistemiċi (ara sezzjoni 4.8).
English: OUTER CARTON
Maltese: Monitoraġġ
English: You may also feel a ‘withdrawal symptom'.
Maltese: Jista' jkun li tħoss ukoll ‘sintomu tal-irtirar'.
English: What you need to know before you take Neofordex 3.
Maltese: X'għandek tkun taf qabel ma tieħu Neofordex 3.
English: Efficacy of hormone replacement therapy may also be reduced.
Maltese: L-effikaċja tat-terapija ta' sostituzzjoni tal-ormoni tista' titnaqqas ukoll .
English: Neofordex has moderate influence on the ability to drive and use machines.
Maltese: Neofordex għandu effett moderat fuq il-ħila għas-sewqan u t-tħaddim ta' magni.
English: Intervet PortugalSaúde Animal, Lda Rua Agualva dos Açores, n.º 16,
Maltese: Rua Agualva dos Açores, n.º 16,
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland
English: 3) The minimum efficacious titre is 4.0 TCID50
Maltese: 3) L-effiċjenza minima ta' titrazzjoni hija 4.0 TCID50
English: 1 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: 1 Il-linja gwida tas-CVMP fuq il-ħtiġijiet tad-dejta li jappoġġaw il-klejms ta' stabilità għall-vaċċini veterinarji (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
English: The Netherlands
Maltese: Nederland
English: 0.02 (mean 0.05) which is within assay variability;
Maltese: 02 (medja 0.05) li jaqa' fil-varijabilità tal-analiżi;
English: Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus.
Maltese: Porcilis PRRS huwa prodott mediċinali immunoloġiku veterinarju li fih il-virus u s-Sindromu Riproduttiv Respiratorju tal-Porċini (Porcine Reproductive and Respiratory Syndrome (PRRS) virus).
English: Dosage:
Maltese: Doża:
English: Luxembourg Intervet International BV Wim de Körverstraat 35
Maltese: Lussemburgu Intervet International BV Wim de Körverstraat 35
English: Intramuscular injection: 2 ml in the neck.
Maltese: Injezzjoni fil-muskolu: 2 ml fl-għonq.
English: Belgium Intervet International BV Wim de Körverstraat 35
Maltese: Belġjum Intervet International BV Wim de Körverstraat 35
English: The solvent includes dl--tocopherol acetate as adjuvant.
Maltese: Is-solvent jinkludi l-aċtu dl--tocopherol bħala adjuvant.
English: The live vaccine is composed of a lyophilised fraction, which includes the antigen, and a solvent for suspension for injection.
Maltese: Il-vaċċin ħaj huwa ffurmat minn frazzjoni lijofilizzata, li tinkludi antiġen, u solvent għal sospensjoni għal injezzjoni.
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 PRRS 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 tat-Tip II suġġetta għall-Proċedura ta' Rikonoxximent Reċiproku għall-Awtorizzazzjonijiet tat-Tqegħid fis-suq tal-prodott veterinarju mediċinali Porcilis PRRS fil-qafas ta' Artikolu 6 tar-Regolamenti tal-Kummissjoni (KE) Nru 1084/2003.
English: 2) The apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Maltese: 2) It-tnaqqis marġinali fuq medda ta' siegħa mit-titrazzjoni fil-ħin tat-taħlita (6.4/6.2
English: 2.1 In-use shelf-life proposed after mixing the two products (Porcilis PRRS and Porcilis M Hyo)
Maltese: 2.1 Il-ħajja ta' fuq l-ixkaffa proposta wara li ż-żewġ prodotti jitħalltu (Porcilis PRRS u Porcilis M Hyo)
English: Strength
Maltese: Awstrija
English: 1 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 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: 1 Linjagwida tas-CVMP fuq il-ħtiġijiet għal amminstrazjoni konkurrenti tal-prodotti mediċinali immunoloġiċi veterinarji (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf awtorizzazzjoni għat-tqegħid fis-suq permezz ta' diversi studji laboratorji u studji fuq il-post wera li l-grad ta' protezzjoni mitlub mill-prodotti individwali ma nbidilx minħabba t-taħlit talprodotti.
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-parametri tal-effiċjenza tat-tul tal-immunità minħabba interferenza kkawżata mit-taħlit taż-żewġ prodotti.
English: Benefit/Risk assessment
Maltese: 3. Valutazzjoni tal-Benefiċċju/Valutazzjoni tar-Riskju
English: List of the names, pharmaceutical form, strength of the Veterinary medicinal products, 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: The marketing authorisation holder considered that, based on the Guideline on requirements for concurrent administration of immunological veterinary medicinal products1, 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 ikkonsidra li, skont il-linja gwida tasCVMP fuq il-ħtiġijiet għall-amministrazzjoni attwali ta' prodotti mediċinali veterinarji immunoloġiċi1, id-dejta ta' effiċjenza tal-prodotti individwali, fosthom it-tul tal-immunità, jistgħu jiġu applikati għall-użu attwali tagħhom jekk jintwera nuqqas ta' interferenza immunoloġika.
English: 12 months (after storage by the manufacturer at ≤-20°C during maximum 12 months) Diluent: in glass vials 4 years, in PET vials 24 months After reconstitution: 3 hours at room temperature.
Maltese: Diljuwent: fi fjali tal-ħġieġ 4 snin, fi fjlai PET 24 xahar Wara li jiġi rikostitwit; 3 sigħat f'temperatura tal-kamra.
English: Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl-α-tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Maltese: Rigward Porcilis M Hyo d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq issottometta dejta tal-kontenut tal-adjuvant (dl-α-tocopherol acetate), pH u l-isterilità tat-taħlita wara r rikostruzzjoni taż-żewġ lottijiet ta' Porcilis PRRS f'żewġ lottijiet ta' Porcilis M Hyo wara ħażnata' 3 sigħat f'temperatura ambjentali normali.
English: 4.9 Amounts to be administered and administration route Reconstitute the vaccine with the corresponding adjuvating diluent (use only Diluvac Forte).
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni Rikostitwixxi l-vaċċin bid-diljuwent korrispondenti (uża biss Diluvac Foerte)
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS PRRS (SEE ANNEX I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' PORCILIS PRRS (ARA ANNESS I)
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 wrew li kien hemm tnaqqis limitat fit-titrazzoni tal-virus PRRS wara li tħallat ma' Porcilis M Hyo (it-tnaqqis medju wara l-imsemmija siegħa tal-ħajja ta' fuq l-ixkaffa kienet ta' 0.05 log).
English: After mixing with Porcilis M Hyo: 1 hour (at room temperature)
Maltese: Wara li jitħallat ma' Porcilis PRRS: 1 siegħa (temperature tal- karma)
English: SPECIAL STORAGE PRECAUTIONS
Maltese: TAL-PRODOTT MEDIĊINALI
English: Thus, the overall the benefit/risk balance is considered to be positive.
Maltese: Għaldaqstant, il-bilanċ ġenerali ta' benefiċċju/riskju huwa meqjus bħala pożittiv.
English: Use sterile syringes and needles or clean intradermal equipment.
Maltese: Uża siringi u labar sterlizzati jew apparat għall-taħt il-ġilda nadif.
English: Following the absence of agreement between the Reference Member State (the United Kingdom) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Maltese: Wara n-nuqqas ta' ftehim bejn l-Istat Membru ta' Referenza (ir-Renju Unit) u l-Istat Membru Kkonċernat (Spanja) fil-jum 90 tal-proċedura CMDv, il-kwistjoni għaddiet għand is-CVMP nhar it-2 ta' Ottubru 2009.
English: A single dose (2 ml) of Porcilis PRRS mixed with Porcilis M Hyo is given intramuscularly in the neck.
Maltese: (2 ml) of Porcilis PRRS mħalta ma' Porcilis M Hyo tingħat fil-muskolu flgħonq.
English: Do not mix with any other veterinary medicinal product, except the diluent supplied with the product or with Porcilis M Hyo.
Maltese: Tħallatx ma prodotti mediċinali veterinarji oħra minbarra mad-diljuwent provdut jew ma Porcilis M Hyo.
English: 4.8 Interaction with other medicinal products and other forms of interaction Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra Data fuq is-sigurtà u l-effikaċja fi ħnieżer għal-qatla minn eta`ta' 4 ġimgħat il-fuq hija disponibli, li turi li dan il-vaċċin jista' jitħallat mal Porcilis M hyo.
English: The claims of Porcilis PRRS, indications section of SPC (section 4.2) are: “For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus.
Maltese: 2.2 Ġustifikazzjoni tal-klejm attwali għal Porcilis PRRS rigward titjib sinifikanti tarriżultati (tnaqqis fil-mewt minħabba infezzjonijiet ta' PRRS, u żvilupp fit-tkabbir aħjar ta' kuljum u l-ikel) sat-tmiem tal-perjodu tas-smin meta mħallat ma' Porcilis M Hyo. Il-klejms ta' Porcilis PRRS, taqsima tal-indikazzjonijiet ta' SPC (taqsima 4.2) huma: “Għat-tilqim attiv ta' majjali klinikament f'saħħithom f'ambjent ikkontaminat mill-virus tal-PRRS, għat-tnaqqis ta' viraemia kkawżat minn infezzjoni bit-tipi Ewropej tal-virus PRRS.
English: The marketing authorisation holder has provided data of the PRRS virus titration after mixing Porcilis PRRS with Porcilis M Hyo at 0, 1, 2 and 3 hours.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda dejta fuq it-titrazzjoni tal-virus tal-PRRS wara li Porcilis PRRS tħallat ma' Porcilis M Hyo f'intervalli ta' 0, 1, 2 u 3 sigħat.
English: In order to ascertain that there is no significant decrease in the titre right after mixing (i.e., at t=0), it was considered important to know the titre at release (or after reconstitution in the diluent fraction of Porcilis PRRS).
Maltese: Sabiex ikun assigurat li ma jkunux hemm tnaqqis sinifikanti fit-titrazzjoni eżatt wara t-taħlit (i.e., t=0), ġie meqjus importanti li tkun magħrufa t-titrazzjoni fil-ħin tal-ħruġ tat-taħlita (jew wara li tkun saret fi frazzjoni ta' dilwent ta' Porcilis PRRS).
English: The marketing authorisation holder provided data for PRRS virus titres of two batches of Porcilis PRRS reconstituted with each of ten batches of Porcilis M Hyo after 0, 1, 2 and 3 hours of storage at room temperature.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda dejta fuq it-titrazzjoni tal-virus tal-PRRS ta' żewġ lottijiet ta' Porcilis PRRS rikonstitwiti b'kull għaxar lottijiet ta' Porcilis M Hyo wara intervalli ta' 0, 1, 2 u 3 sigħat ta' ħażna f'temperatura ambjentali normali.
English: The National Competent Authority of Spain was concerned that some aspects regarding the quality and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Maltese: L-Awtorità Nazzjonali Kompetenti ta' Spanja kienet ikkonċernata li xi aspetti rigward il-kwalità u l-effiċjenza wara t-taħlit taż-żewġ prodotti (Porcilis PRRS u Porcilis M Hyo) ma kinux iġġustifikati kif xieraq.
English: As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Maltese: Għal dak li jirrigwarda l-ġustifikazzjoni għaliex ebda eżami ta' potenza tal-komponenti ta' Porcilis M Hyo ma sar fuq il-vaċċini mħallta kemm minnufih kif ukoll wara l-użu propost ta' ħajja fuq l-ixkaffa, id-deterntur tal-awtorizzazzjoni għat-tqegħid fis-suq iġġustifika ruħu għaliex ma sarx għaliex ma sarx eżami tal-potenza billi qal li l-komponenti fil-vaċċini mħallta skont id-dispożizzjoni tas-sigurtà u l-effiċjenza wrew li ma hemmx interazzjonijiet fit-taħlita nnifisha li jaffettwaw il-potenza tal-prodott imħallat.
English: 4) this means that in the worst case scenario of a batch at the end of shelf being mixed there will be no statistically significant drop below the minimum titre over the claimed in-use shelf life of 1 hour.
Maltese: 4) dan ifisser li fl-agħar ċirkostanzi ta' lott li jkun qrib l-aħħar tal-ħajja fuq l-ixkaffa u jitħallat, ma jkunx hemm ebda tnaqqis statistikament sinifikanti taħt it-titrazzjoni minima fuq l-imsemmija ħajja ta' fuq l-ixkaffa ta' siegħa.
English: Batch release protocols for the in-use stability studies of Porcilis PRRS and Porcilis M Hyo were provided.
Maltese: Il-protokols tal-lottijiet għall-użu fi studji stabbli ta' Porcilis PRRS u Porcilis M Hyo ngħataw.