FrancophonIA/ELRC3.0 huggingface dataset:
English: Information to healthcare professionals Following an evaluation of the data on the risks of valproate use during pregnancy, the recommendations for the use of valproate in women and girls have been updated:
Maltese: Informazzjoni lill-professjonisti tal-kura tas-saħħa Wara evalwazzjoni tad-data dwar ir-riskji tal-użu ta' valproate waqt it-tqala, ir-rakkomandazzjonijiet għall-użu ta' valproate fin-nisa u t-tfajliet ġew aġġornati:
English: Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Gamla farmaewtika
English: EU Number
Maltese: ANNESS I
English: Eklira Genuair Placebo
Maltese: Eklira Genuair Plaċebo
English: Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju 2012 Data tal-ewwel tiġdid: 20 ta' April 2017
English: - The other ingredient is lactose monohydrate (refer to Section 2 “Eklira Genuair contains lactose”).
Maltese: - Is-sustanza l-oħra hija lactose monohydrate (irreferi għal Sezzjoni 2 “Eklira Genuair fih lactose”).
English: Eklira Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Maltese: [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; volum residwu [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) u tejjeb ukoll il- kapaċità minima ta' teħid 'il ġewwa tan-nifs (b'0.078 L; 95% CI=0.01, 0.145; p=0.025) u naqqas id-dispnea matul eżerċizzju (skala ta' Borg) (b'0.63 unitajiet Borg; 95% CI=1.11, 0.14; p=0.012).
English: Approximately 48% of enrolled patients had a prior history of at least 1 documented previous cardiovascular event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral vascular disease or history of claudication (13.6%).
Maltese: Madwar 48 % tal-pazjenti rreġistrati kellhom storja preċedenti ta' mill-inqas avveniment kardjovaskulari 1 preċedenti dokumentat; marda ċerebrovaskulari (13.1%), marda tal-arterja koronarja (35.4%), marda vaskulari periferali jew storja ta' klawdikazzjoni (13.6%).
English: Administration of Eklira Genuair may cause paradoxical bronchospasm.
Maltese: L-għoti ta' Eklira Genuair jista' jikkawża bronkospażmi paradossiċi.
English: 1.87-fold c increase in likelihood
Maltese: żieda ta' 1.87 drabi fil-probabbiltà
English: Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Maltese: Eklira Genuair huwa indikat bħala trattament ta' manutenzjoni bi bronkodilatatur sabiex itaffi ssintomi fil-pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD) (ara sezzjoni 5.1).
English: The most frequently reported adverse reactions with Eklira Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni b'Eklira Genuair kienu l-uġigħ ta' ras (6.6%) u nasofarinġite (5.5%).
English: Eklira Genuair contains lactose
Maltese: Eklira Genuair fih lactose
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of P-glycoprotein (P-gp), or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).
Maltese: Studji in vitro wrew li aclidinium bromide jew il-metaboliti ta' aclidinium bromide fid-doża terapewtika mhumiex mistennija li jikkawżaw interazzjonijiet ma' sustanzi attivi li huma substrati ta' glikoproteina-P (P-gp), jew sustanzi attivi metabolizzati minn enzimi taċ-ċitokrom P450 (CYP450) u esterases (ara sezzjoni 5.2).
English: EU/1/12/778/001 30 doses
Maltese: EU/1/12/778/001 30 doża
English: Experience in patients with cardiovascular comorbidities in clinical trials is limited (see section 5.1).
Maltese: Esperjenza f'pazjenti b'komorbiditajiet kardjovaskulari filprovi kliniċi hija limitata (ara sezzjoni 5.1).
English: EU/1/12/778/002 60 doses
Maltese: EU/1/12/778/002 60 doża
English: What Eklira Genuair contains - The active substance is aclidinium bromide.
Maltese: - Is-sustanza attiva hi aclidinium bromide.
English: Patients treated with Eklira Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 95% CI 0.68 to 0.89; p<0.001).
Maltese: Il-pazjenti ttrattati b'Eklira Genuair urew tnaqqis statistikament sinifikanti ta' 22 % meta mqabbel ma' plaċebo (proporzjon tar-rata [RR] 0.78; 95% CI 0.68 sa 0.89; p<0.001).
English: The active ingredient of Eklira Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators.
Maltese: Is-sustanza attiva ta' Eklira Genuair hija aclidinium bromide, li tappartjeni għal grupp ta' mediċini msejħa bronkodilataturi.
English: EU/1/12/778/003 3 inhalers each containing 60 doses
Maltese: EU/1/12/778/003 3 inalaturi b'kull wieħed fih 60 doża
English: In the 6-month study, patients receiving Eklira Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1).
Maltese: Fl-istudju ta' 6 xhur, il-pazjenti li rċivew Eklira Genuair 322 µg darbtejn kuljum kellhom titjib klinikament sinifikanti fil-funzjoni tal-pulmun tagħhom (kif imkejjel mill-FEV1).
English: Similar observations were made with Eklira Genuair in the 3 month study.
Maltese: Kien hemm osservazzjonijiet simili b'Eklira Genuair fl-istudju ta' 3 xhur.
English: • Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Maltese: L-indikatur tad-doża jiċċaqlaq bil-mod minn 60 għal 0: 60, 50, 40, 30, 20, 10, 0.
English: The median time on-study in the Eklira Genuair and placebo groups was approximately 1.4 and 1.3 years, respectively.
Maltese: Iż-żmien medjan fuq listudju fil-gruppi ta' Eklira Genuair u tal-plaċebo kien madwar 1.4 u 1.3 snin, rispettivament.
English: How to store Eklira Genuair
Maltese: Tużax Eklira Genuair
English: The effect of aclidinium bromide on the occurrence of major adverse cardiovascular events (MACE) was assessed in a randomised, double-blind, placebo-controlled, parallel-group study in 3630 adult patients between 40 and 91 years of age with moderate to very severe COPD, treated for up to 36 months.
Maltese: L-effett ta' aclidinium bromide fuq l-okkorrenza ta' avvenimenti kardjovaskulari avversi maġġuri (MACE, major adverse cardiovascular events) ġie vvalutat fi studju randomizzat, double-blind, ikkontrollat bil-plaċebo u ta' grupp parallel fi 3630 pazjent adult bejn l-età ta' 40 sa 91 sena b'COPD moderata għal severa ħafna, ittrattati sa 36 xahar. 58.7 % kienu rġiel u 90.7 % kienu Bojod, b'FEV1 ta' wara l-bronkodilatur medju ta' 47.
English: In addition, no clinically significant effects of Eklira Genuair on cardiac rhythm were observed on 24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Eklira Genuair 322 µg twice daily).
Maltese: Barra minn hekk, ma ġie osservat l-ebda effett klinikament sinifikanti ta' Eklira Genuair fuq ir-ritmu kardijaku matul monitoraġġ Holter ta' 24 siegħa wara trattament ta' 3 xhur ta' 336 pazjent (li 164 minnhom irċevew Eklira Genuair 322 µg darbtejn kuljum).
English: The Eklira Genuair Phase III clinical development programme included 269 patients treated with Eklira Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 190 patients treated with Eklira Genuair 322 µg twice daily in one 3-month randomised, placebocontrolled study.
Maltese: III ta' Eklira Genuair inkluda 269 pazjent ittrattat b'Eklira Genuair 322 µg darbtejn kuljum fi studju wieħed ta' sitt xhur li fih il-parteċipanti ntgħażlu b'mod każwali kkontrollat bi plaċebo u 190 pazjent ittrattat b'Eklira Genuair 322 µg darbtejn kuljum fi studju wieħed li fih il-parteċipanti ntgħażlu b'mod każwali, li dam tliet xhur, ikkontrollat bi plaċebo.
English: In a 3-week crossover, randomised, placebo-controlled clinical study Eklira Genuair was associated with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds).
Maltese: Fi studju kliniku crossover ta' tliet ġimgħat, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, Eklira Genuair ġie assoċjat ma' titjib statistikament sinfikanti li tejjeb b'mod sinifikanti lħin ta' kapaċità li wieħed jissaporti l-eżerċizzju meta mqabbel ma' plaċebo ta' 58 sekonda (95% CI=9108; p=0.021; valur ta' qabel il-kura: 486 sekonda).
English: The median time on-treatment in the Eklira Genuair and placebo groups was 1.1 and 1 year, respectively.
Maltese: Iż-żmien medjan fuq it-trattament filgrupp ta' Eklira Genuair kif ukoll tal-plaċebo kien 1.1 u sena, rispettivament.
English: The following side effects may occur whilst using Eklira Genuair: Common: may affect up to 1 in 10 people - Headache - Inflammation of the sinuses (sinusitis) - Common cold (nasopharyngitis) - Cough - Diarrhoea - Nausea
Maltese: L-effetti sekondarji li ġejjin jistgħu jseħħu filwaqt li tuża Eklira Genuair: Komuni: jistgħu jaffettwaw sa 1 minn 10 persuni - Uġigħ ta' ras - Infjammazzjoni tas-sinusijiet (sinusite) - Riħ (nażofarinġite) - Sogħla - Dijarea - Nawsja
English: Eklira Genuair 322 mcg inhalation powder aclidinium (aclidinium bromide) Inhalation use
Maltese: Eklira Genuair 322 mcg trab li jittieħed man-nifs aclidinium (aclidinium bromide)
English: In addition, Eklira Genuair showed a statistically significant reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006).
Maltese: Barra minn hekk, Eklira Genuair wera tnaqqis statistikament sinifikanti ta' 35 % fir-rata ta' dħul fl-isptar minħabba aggravar ta' COPD waqt it-trattament matul l-ewwel sena meta mqabbel ma' plaċebo (RR 0.65; 95% CI 0.48 sa 0.89; p=0.006).
English: OTHER
Maltese: AR
English: Eklira Genuair 322 micrograms inhalation powder Aclidinium (aclidinium bromide)
Maltese: Eklira Genuair 322 mikrogramma trab li jittieħed man-nifs aclidinium (aclidinium bromide)
English: Eklira Genuair 322 micrograms inhalation powder aclidinium (aclidinium bromide)
Maltese: Eklira Genuair 322 mikrogramma trab li jittieħed man-nifs Aclidinium (aclidinium bromide)
English: The Eklira Genuair group showed a statistically significant delay in the time to first moderate or severe exacerbation while on-treatment compared to the placebo group.
Maltese: Il-grupp ta' Eklira Genuair wera dewmien statistikament sinifikanti fiż-żmien għall-ewwel aggravar moderat jew sever waqt it-trattament meta mqabbel mal-grupp tal-plaċebo.
English: The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Eklira Genuair) observed with Eklira Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.
Maltese: Il-frekwenzi assenjati għall-effetti mhux mixtieqa ta' hawn taħt huma bbażati fuq rati ta' inċidenza mhux aġġustati ta' reazzjonijiet avversi (jiġifieri avvenimenti attribwiti lil Eklira Genuair) osservati b'Eklira Genuair 322 µg (636 pazjent) fl-analiżi miġbura ta' prova klinika waħda ta' 6 xhur u tnejn ta' 3 xhur fejn il-pazjenti ntgħażlu b'mod każwali, ikkontrollata bil-plaċebo.
English: Eklira Genuair did not increase the MACE risk in patients with COPD compared to placebo when added to current background therapy (hazard ratio (HR) 0.89; 95% CI: 0.64, 1.23).
Maltese: Eklira Genuair ma żiedx ir-riskju ta' MACE f'pazjenti b'COPD meta mqabbel ma' plaċebo meta ġie miżjud ma' terapija ta' sfond attwali (proporzjon ta' riskju (HR) 0.89; 95% CI: 0.64, 1.23).
English: Clinical efficacy studies showed that Eklira Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL).
Maltese: [FEV1]) fuq 12-il siegħa b'għoti filgħodu u filgħaxija, li kien evidenti fi żmien 30 minuta mill-ewwel doża (żidiet mil-linja bażi ta' 124-133 mL).
English: Regular use of Eklira Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Maltese: Użu regolari ta' Eklira Genuair jista' jgħinek meta jkollok nuqqas ta' nifs kontinwu relatat mal-marda tiegħek biex jgħinek tnaqqas kemm jista' jkun l-effetti tal-marda fil-ħajja ta' kuljum tiegħek u tnaqqas in-numru ta' feġġ f'daqqa (l-aggravar tas-sintomi tiegħek tas-COPD għal diversi jiem).
English: A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Eklira Genuair up to 36 months did not identify other adverse reactions.
Maltese: Prova kkontrollata bil-plaċebo f'1791 pazjent b'COPD moderata għal severa ħafna ttrattati b'Eklira Genuair sa 36 xahar ma identifikatx reazzjonijiet avversi oħra.
English: Disease-Specific Health Status and Symptomatic Benefits Eklira Genuair provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George's Respiratory Questionnaire [SGRQ]).
Maltese: Stat tas-Saħħa Speċifiku għall-Marda u l-Benefiċċji Sintomatiċi Eklira Genuair ipprovda titjib klinikament sinifikanti fin-nuqqas ta' nifs (evalwat billi ntuża l-Indiċi ta' Qtugħ ta' nifs ta' Transizzjoni (Transition Dyspnoea Index)
English: COPD is a long-term disease; therefore, it is recommended that Eklira Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Maltese: COPD hija marda fit-tul; għaldaqstant, huwa rrakkomandat li Eklira Genuair jintuża kuljum, darbtejn kuljum u mhux biss meta jinħassu s-sintomi ta' problemi fit-teħid ta' nifs jew sintomi oħrajn ta' COPD.
English: Stop taking Eklira Genuair and seek medical help immediately: - if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Maltese: Tiħux aktar Eklira Genuair u fittex għajnuna medika minnufih: - jekk tħoss tagħfis fis-sider, sogħla, tħarħir jew qtugħ ta' nifs dritt wara li tuża l-mediċina.
English: Patients treated with Eklira Genuair required less rescue medication than patients treated with placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]).
Maltese: Pazjenti ttrattati b'Eklira Genuair kienu jeħtieġu inqas mediċina ta' salvataġġ mill-pazjenti ttrattati bi plaċebo (tnaqqis ta' 0.95 għafsiet kuljum f'6 xhur [p=0.005]).
English: Eklira Genuair 322 micrograms inhalation powder
Maltese: Eklira Genuair 322 mikrogramma trab li jittieħed man-nifs
English: Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Maltese: Studji f'annimali urew tossiċità tal-feti biss f'livelli ta' doża ferm ogħla mill-espożizzjoni massima talbniedem għal aclidinium bromide (ara sezzjoni 5.3).
English: Eklira Genuair also improved daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning symptoms.
Maltese: Eklira Genuair tejjeb ukoll is-sintomi ta' kuljum tas-COPD (produzzjoni ta' qtugħ ta' nifs, sogħla u bżieq) u s-sintomi ta' filgħaxija u ta' kmieni filgħodu.
English: The primary safety endpoint was the time to first occurrence of MACE, defined as any of the following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal ischemic stroke.
Maltese: Il-punt tat-tmiem tas-sigurtà primarja kien iż-żmien għall-ewwel okkorrenza ta' MACE, definit bħala xi wieħed mill-avvenimenti aġġudikati li ġejjin: mewt kardjovaskulari, infart mijokardijaku (MI) mhux fatali, jew puplesija iskemika mhux fatali.
English: The main plasma protein that binds aclidinium bromide is albumin.
Maltese: Il-proteina tal-plażma ewlenija li twaħħal aclidinium bromide hija l-albumina.
English: There is no relevant use of Eklira Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Maltese: Ma hemm l-ebda użu relevanti ta' Eklira Genuair fit-tfal u l-adoloxxenti (età taħt it-18-il sena) għallindikazzjoni tas-COPD.
English: Slovenská republika AstraZeneca AB, o.z.
Maltese: United Kingdom AstraZeneca UK Ltd
English: Adjuvant: Carbomer 1 mg.
Maltese: Carbomer 1 mg.
English: * Relative potency (ELISA test) by comparison with a reference vaccine
Maltese: * Potenza Relattiva (test ELISA) permezz ta' paragun ma' tilqima ta' referenza
English: Missouri, 64506
Maltese: Joseph, Missouri, 64506 L-ISTATI
English: Adjuvant: Carbomer
Maltese: Carbomer
English: 10 ml (10 doses) 50 ml (50 doses) 100 ml (100 doses) 250 ml (250 doses) 12 x 10 ml (12 x 10 doses) 12 x 50 ml (12 x 50 doses) 12 x 100 ml (12 x 100 doses) 12 x 250 ml (12 x 250 doses)
Maltese: 10 ml (10 dożi) 50 ml (50 doża) 100 ml (100 doża) 250 ml (250 doża) 12 x 10 ml (12 x 10 dożi) 12 x 50 ml (12 x 50 doża) 12 x 100 ml (12 x 100 doża) 12 x 250 ml (12 x 250 doża)
English: Store and transport refrigerated (2 C-8 C).
Maltese: Aħżen u ttrasporta fil-friġġ (2C-8C).
English: Date of first authorisation: 24.05.2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24.05.2017
English: 10 ml (10 doses) 50 ml (50 doses)
Maltese: 10 ml (10 dożi) 50 ml (50 doża)
English: STATEMENT OF ACTIVE SUBSTANCE
Maltese: TAS-SUSTANZA ATTIVA
English: • Use the same volumes of Ingelvac PCV FLEX and Ingelvac MycoFLEX.
Maltese: • Uża l-istess volumi ta' Ingelvac PCV FLEX u Ingelvac MycoFLEX.
English: One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer 1 mg.
Maltese: Doża waħda (1 ml) fiha: Circovirus tal-qżieqeż ta' tip 2 proteina ORF2 Carbomer 1 mg.
English: Ingelvac PCV FLEX suspension for injection for pigs
Maltese: VETERINARJU Ingelvac PCV FLEX suspensjoni għall-injezzjoni għal qżieqeż
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurati, inklużi rapporti iżolati).
English: For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2).
Maltese: Għal tilqima attiva ta' qżieqeż mingħajr antikorpi miksubin maternalment ta' PCV2 mill-età ta' ġimagħtejn kontra circovirus tal-qżieqeż ta' Tip 2 (PCV2).
English: One dose (1 ml): Porcine circovirus type 2 ORF2 protein Carbomer
Maltese: Doża waħda (1 ml): Circovirus tal-qżieqeż ta' tip 2 proteina ORF2 Carbomer
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 are 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 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Porcine circovirus type 2 ORF2 protein: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U INGREDJENT OĦRA Doża waħda (1 ml) fiha: circovirus tal-qżieqeż ta' tip 2 proteina ORF2: * Potenza Relattiva (test ELISA) permezz ta' paragun ma' tilqima ta' referenza Sustanza mhux attiva:
English: Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces mortality, clinical signs and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Maltese: Skont kundizzjonijiet ta' sfida sperimentali li fihom annimali seronegattivi biss ġew inklużi, intwera li t-tilqima tnaqqas il-mortalità, is-sinjali kliniċi u leżjonijiet f'tessuti limfojdi assoċjati ma' marda marbuta ma' PCV2 (PCVD).
English: Active substance: Porcine circovirus type 2 ORF2 protein
Maltese: Ċircovirus tal-qżieqeż ta' tip 2 ORF2 proteina
English: Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).
Maltese: Daqsijiet tal-pakkett ta' flixkun 1 jew ta' 12-il flixkun ta' 10 ml (10 dożi), 50 ml (50 doża), 100 ml (100 doża), jew 250 ml (250 doża).
English: Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: 10 ml, 50 ml bottle
Maltese: Flixkun ta' 10 ml, 50 ml
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - 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)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurati)
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi: a) l-għotja tal-prodott lill-annimali tinterferixxi mal-implimentazzjoni ta' programm nazzjonali għad-djanjosi, il-kontroll jew l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni tal-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali kkurati;