FrancophonIA/ELRC3.0 huggingface dataset:
English: It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle.
Maltese: Din timblokka l-azzjoni tal-enzima msejħa NS3-4A proteażi fil-virus tal-epatite Ċ, li hija essenzjali għaċ-ċiklu tal-ħajja tiegħu.
English: The third study showed that in patients treated with Incivo, giving peginterferon alfa and ribavirin for six months was as effective as giving these medicines for one year, since 92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients
Maltese: It-tielet studju wera li fil-pazjenti li ngħataw kura b'Incivo, l-għoti tal-peginterferonu alfa u tar-ribavirina tul sitt xhur kien effikaċi daqs li kieku kienu ngħataw dawn il-mediċini tul sena, peress li 92% tal-pazjenti li ħaduhom tul sitt xhur kellhom riżultat negattiv għall-epatite Ċ apparagun ma' 88% tal-pazjenti li ħaduhom tul sena.
English: Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin.
Maltese: Iż-żewġ studji qabblu lil Incivo ma' plaċebo (kura finta) li żdied ma' kors bil-peginterferonu alfa u bir-ribavirina.
English: Incivo must not be given in combination with several other medicines, including those which are affected by or affect the CYP3A gene and Class Ia or III antiarrhythmics.
Maltese: Incivo ma għandux jingħata flimkien ma' bosta mediċini oħra, inklużi dawk li jaffettwaw l-ġene CYP3A u l-antiarritmiċi tal-Klassi
English: The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.
Maltese: Il-kumpanija li tqiegħed Incivo fis-suq ser tagħti lit-tobba kollha li mistennija jippreskrvuh pakkett edukattiv b'informazzjoni importanti dwar is-sigurtà fuq ir-riskji ewlenin bil-kura b'Incivo, b'mod partikulari r-riskju ta' raxx u reazzjonijiet severi tal-ġilda.
English: When Incivo is added to peginterferon alfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.
Maltese: Din twaqqaf il-virus tal-epatite Ċ milli jirreplika fiċ-ċelloli ospitanti infettati tal-ġisem. Meta Incivo jiżdied malpeginterferonu alfa u mar-ribavirina (il-kura standard attwali kontra l-epatite Ċ), tiżdied il-probabbiltà li jinqatel il-virus.
English: The CHMP considered that adding Incivo to standard treatment represents a major advance in treating the most common type of hepatitis C virus.
Maltese: Is-CHMP qies li ż-żieda ta' Incivo mal-kura standard tirrappreżenta avvanz maġġuri fil-kura tal-aktar tip komuni tal-virus tal-epatite Ċ.
English: The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing authorisation.
Maltese: ikkonkluda li l-benefiċċji ta' Incivo kienu akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Cancer Patients 2014, Chapter 15, pp.251-269.
Maltese: Renal Disease in Cancer Patients 2014, Chapter 15, pp.251-269.
English: 6 Inoue, A. et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis.
Maltese: et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis.
English: In renal impairment (creatinine clearance (CrCl) 15-50 mL/min) a dose reduction of 25% is recommended.
Maltese: F'indeboliment renali (tneħħija tal-kreatinina (CrCl) 15-50 mL/min) huwa rakkomandat tnaqqis fid-doża ta' 25 %.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: Etoposide phosphate injection is supplied as a nonpyrogenic lyophilized powder intended for reconstitution and/or dilution with a suitable parenteral vehicle prior to intravenous (IV) administration and is available as 114 mg etoposide phosphate (100 mg etoposide equivalent) single dose sterile vial and 1140 mg etoposide phosphate (1000 mg etoposide equivalent) pharmacy bulk vial (Germany only).
Maltese: L-injezzjoni etoposide phosphate hija fornuta bħala trab lajfolizzat nonpiroġeniku intiż għarrikostituzzjoni u/jew għad-dilwizzjoni b'mezz parenterali xieraq qabel għoti ġol-vini (IV) u jiġi bħala kunjett sterili ta' doża waħda 114 mg etoposide phosphate (100 mg etoposide ekwivalenti) u kunjett bl-ingrossa tal-ispiżeriji 1140 mg etoposide phosphate (1000 mg etoposide ekwivalenti) (il-Ġermanja biss).
English: Etopophos is currently approved in DE, FR, SE and UK.
Maltese: Etopophos bħalissa huwa approvat f'DE, FR, SE u UK.
English: Etopophos and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Maltese: Etopophos u l-ismijiet assoċjati ġew inklużi fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC), imfassal mis-CMDh, skont l-Artikolu 30(2) tadDirettiva 2001/83/KE.
English: Grounds for the CHMP opinion Whereas
Maltese: Raġunijiet għall-opinjoni tas-CHMP
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[1][2][3][4][5].
Maltese: F'pazjenti b'indeboliment renali, is-CHMP qabel li ma jirrakkomandax tnaqqis fid-doża meta t-tneħħija tal-kreatinina tkun > 50 mL/min kif appoġġjat minn letteratura disponibbli [1][2][3][4][5].
English: Kreusser W, Herrmann R, Tschope W, et al. Nephrological complications of cancer therapy.
Maltese: Kreusser W, Herrmann R, Tschope W, et al.
English: The pregnancy section has been revised in line with the relevant guideline[7].
Maltese: Is-sezzjoni tattqala ġiet riveduta f'konformità mal-linja gwida rilevanti[7].
English: The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Maltese: LMAH iddiskuta wkoll tnaqqis fid-doża għal pazjenti b'mard renali tal-aħħar fażi (CrCl < 15 mL/min).
English: Paediatric indications were agreed in the following indications:
Maltese: Ġew maqbula indikazzjonijiet pedjatriċi fl-indikazzjonijiet li ġejjin:
English: 3 Toffoli G, Corona G, Basso B et al. Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
Maltese: 3 Toffoli G, Corona G, Basso B et al.
English: Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
Maltese: Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
English: - Gestational trophoblastic neoplasia
Maltese: - Neoplażija trofoblastika ġestazzjonali
English: In paediatric patients diagnosed with Hodgkin's lymphoma, non-Hodgkin's lymphoma or acute myeloid leukaemia, the CHMP recommended the range of 75 to 150 mg/ m2/day for 2 to 5 days in combination with other antineoplastic agents as supported in studies conducted by major international groups such as The German Society of Paediatric Oncology and Haematology Hodgkin's Disease, The Children's Cancer Group and The European Organization of Research and Treatment of Cancer Children Leukaemia Group among others.
Maltese: F'pazjenti pedjatriċi dijanjostikati b'linfoma ta' Hodgkin, b'limfoma mhux ta' Hodgkin jew b'lewkimja majelojde akuta, is-CHMP irrakkomanda l-medda ta' 75 sa 150 mg/m2/jum għal 2 sa 5 ijiem b'aġenti antineoplastiċi oħra kif appoġġjat fi studji li saru minn gruppi internazzjonali maġġuri bħas-Soċjetà Ġermaniża ta' Onkoloġija u Ematoloġija Pedjatrika Marda ta' Hodgkin, Il-Grupp tal-Kanċer fit-Tfal u LOrganizzazzjoni Ewropea tar-Riċerka u tal-Kura tal-Kanċer tal-Grupp tal-Lewkimja fit-Tfal fost oħrajn.
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Maltese: It-twissijiet speċjali u prekawzjonijiet għall-użu li ġejjin ġew armonizzati fis-sezzjoni 4.4 fejn dawn diġà kienu inklużi f'xi jew f'ħafna mill-SmPCs nazzjonali: majelosoppressjoni, lewkimja sekondarja, sensittività eċċessiva, reazzjoni fis-sit tal-injezzjoni, albumina fis-seru baxxa, funzjoni renali u epatika indebolita, sindrome ta' lijasi tat-tumur u potenzjal mutaġeniku.
English: 2 Arbuck SG, Douglass HO, Crom WR et al. Etoposide Pharmacokinetics in Patients With Normal and Abnormal Organ
Maltese: 2 Arbuck SG, Douglass HO, Crom WR et al.
English: Etopophos contains etoposide phosphate, a pro-drug of etoposide which is rapidly converted to etoposide in vivo.
Maltese: Etopophos fih etoposide phosphate, promediċina ta' etoposide li tinbidel malajr f'etoposide in vivo.
English: The recommended dose in adult patients is 50 to 100 mg/m2/day on days 1 to 5 in line with the current clinical practice guidelines, however when administered on three days (e.g. days 1, 3, and 5) the daily dose that is most commonly used can be either 100 to 120 mg/m2 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Maltese: Id-doża rakkomandata f'pazjenti adulti hija ta' 50 sa 100 mg/m2/jum f'jiem 1 sa 5 f'konformità mallinji gwidi prattiċi kliniċi attwali, madankollu meta jingħata fuq tlett ijiem (eż. jiem 1, 3 u 5) id-doża ta'
English: In section 4.5 of the SmPC the interactions that were documented in the majority of current national SmPCs have been retained in the harmonised text.
Maltese: Fis-sezzjoni 4.5 tal-SmPC, l-interazzjonijiet li ġew iddokumentati fil-maġġoranza tal-SmPCs nazzjonali attwali nżammu fit-test armonizzat.
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Maltese: - Kanċer tal-ovarji: kanċer tal-ovarji mhux epiteljali u kanċer tal-ovarji epiteljali reżistenti għallplatinu/refrattarju
English: The revised indications in section 4.1 of the Summary of Product characteristics (SmPC) are:
Maltese: L-indikazzjonijiet reveduti fis-sezzjoni 4.1 tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) huma:
English: Renal Disease in
Maltese: Anness II
English: Hypersensitivity has been added as contraindication in section 4.3 of the SmPC in line with the guideline on SmPC.
Maltese: Ġiet miżjuda sensittività eċċessiva bħala kontraindikazzjoni fis-sezzjoni 4.3 tal-SmPC f'konformità mallinja gwida dwar l-SmPC.
English: Ann. Oncol.
Maltese: Ann.
English: As regards the posology, section 4.2 of the SmPC, the doses were harmonised for all indications and patient populations - adult and paediatric.
Maltese: Fir-rigward tal-pożoloġija, is-sezzjoni 4.2 tal-SmPC, id-dożi ġew armonizzati għall-indikazzjonijet u lpopolazzjonijiet tal-pazjenti kollha - adulti u pedjatriċi.
English: - Small-cell lung cancer
Maltese: Nephrological complications of cancer therapy.
English: • The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Maltese: • Il-Kumitat irreveda t-totalità tad-data ppreżentata mill-MAH b'appoġġ għall-armonizzazzjoni proposta tal-informazzjoni dwar il-prodott.
English: This has been addressed by a warning in section 4.2 of the SmPC.
Maltese: Dan ġie indirizzat minn twissija fis-sezzjoni 4.2 tal-SmPC.
English: Finally, lactation has also been included as a contraindication with a reference to section 4.6 of the SmPC where lactation is further described.
Maltese: Finalment, it-treddigħ ukoll ġie inkluż bħala kontraindikazzjoni b'referenza għas-sezzjoni 4.6 tal-SmPC fejn huwa deskritt aktar it-treddigħ.
English: Etoposide is a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Maltese: Etoposide huwa derivattiv semisintetiku ta' podophyllotoxin li jkisser DNA b'filament doppju permezz ta' interazzjoni b'DNA-topoisomerase II, jew permezz tal-formazzjoni ta' radikali ħielsa.
English: • The scope of the referral was the harmonisation of the product information,
Maltese: • Il-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tal-informazzjoni dwar il-prodott,
English: The CHMP also noted that etoposide may decrease male fertility.
Maltese: Is-CHMP innota wkoll li etoposide jista' jnaqqas il-fertilità fl-irġiel.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Maltese: Il-bidliet fl-SmPC, meta rilevanti għall-utent, ġew riflessi wkoll fil-PL u approvati mis-CHMP.
English: • The product information proposed by the Marketing Authorisation Holder has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Maltese: • L-informazzjoni dwar il-prodott proposta mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fisSuq ġiet evalwata abbażi tad-dokumentazzjoni ppreżentata u d-diskussjoni xjentifika fi ħdan ilKumitat,
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Etopophos and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri fir-rigward talawtorizzazzjoni tal-prodott imsemmi hawn fuq, fl-14 ta' Ottubru 2015, il-Kummissjoni Ewropea, innotifikat lis-CHMP/Aġenzija Ewropea għall-Mediċini dwar riferiment skont l-Artikolu 30 tadDirettiva 2001/83/KE għal Etopophos u l-ismijiet assoċjati sabiex jiġu riżolti diverġenzi fost linformazzjoni dwar il-prodott awtorizzata fuq livell nazzjonali u b'hekk tiġi armonizzata l-informazzjoni dwar il-prodott madwar l-UE kollha.
English: Etoposide is used for the treatment of various neoplastic diseases.
Maltese: Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
English: With regards to fertility, pregnancy and lactation section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Maltese: Fir-rigward tal-fertilità, it-tqala u t-treddigħ is-sezzjoni 4.6 tal-SmPC, ġiet inkluża informazzjoni indirizzata lil nisa li jistgħu joħorġu tqal fir-rigward tal-kontraċezzjoni fl-irġiel u fin-nisa.
English: - Testicular cancer: first line, recurrent or refractory testicular cancer
Maltese: - Kanċer tat-testikoli: kanċer tat-testikoli tal-ewwel linja, rikorrenti jew refrattarju
English: 81109 Bratislava
Maltese: 81109 Bratislava SLOVAK REPUBLIC
English: Box 37
Maltese: P.O. Box 37
English: 23/25 Avenue du Docteur Lannelongue 75014 Paris FRANCE
Maltese: 23/25 Avenue du Docteur Lannelongue 75014
English: Benefit-risk evaluation
Maltese: 3. Evalwazzjoni benefiċċju-riskju
English: Pfizer Trading Polska Sp. z o.o.
Maltese: Pfizer Trading Polska Sp. z o.o. ul.
English: Product name Pharmaceutical form
Maltese: Għamla Farmaċewtika
English: SLOVAK REPUBLIC
Maltese: Ir-Repubblika Slovakka
English: Pfizer Animal Health BV Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
Maltese: Westlaan 142 2909 LD Capelle a/d Ijssel
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Maltese: lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, razez tal-annimali, mod ta' amministrazzjoni, perjodu ta' tiżmim u detenturi talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: The product has also a claim of partial cross protection against BVDV type 2.
Maltese: Il-prodott għandu wkoll pretensjoni ta' kross-protezzjoni parzjali kontra BVDV tat-tip 2.
English: Since March 2009, over 400 adverse events of bovine neonatal pancytopenia (involving over 2,000 animals) have been reported within eleven European Union (EU) Member States where the product is authorised.
Maltese: Minn Marzu 2009, ġew irrapportati avvenimenti avversi ta' pancytopenia bovina fl-għoġġiela tat-twelid (li involvew aktar minn 2,000 annimal) fi ħdan ħdax-il Stat Membru tal-Unjoni Ewropea fejn huwa awtorizzat il-prodott.
English: Slovenia
Maltese: is-Slovenja
English: The marketing authorisation holder voluntarily stopped the sales of the product from the market in Germany in April 2010 and from all other concerned EU Member States in June 2010.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq waqqaf b'mod volontarju l-bejgħ tal-prodott missuq tal-Ġermanja f'April 2010 u mill-Istati Membri tal-UE kkonċernati kollha f'Ġunju 2010.
English: Pregsure BVD is an inactivated vaccine for the immunisation of female cattle to prevent bovine viral diarrhoea virus (BVDV) type 1 (cytopathogenic strain 5960) transplacental infection and the birth of BVDV type 1 persistently infected calves.
Maltese: Pregsure BVD huwa vaċċin inattivat għat-tilqim ta' baqar nisa għall-prevenzjoni ta' infezzjoni transplaċentali mill-virus tad-dijarrea virali bovina (BVDV) tat-tip 1 u t-twelid ta' għoġġiela infettati b'mod persistenti minn BVDV tat-tip 1.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that the pharmacovigilance data (adverse event reports) indicated a general trend between reported events of bovine neonatal pancytopenia and the temporal and geographical distribution of Pregsure BVD sales, including the number of doses sold in the different EU Member States.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkunsidra li d-dejta ta' farmakoviġilanza (rapporti ta' avvenimenti avversi) indikaw tendenza ġenerali bejn rapporti ta' avvenimenti ta' pancytopenia bovina fl-għoġġiela tat-twelid u d-distribuzzjoni temporali u ġoegrafika tal-bejgħ ta' Pregsure BVD, inkluż in-numru ta' dożi mibjugħin fi Stati Membri tal-UE differenti.
English: PFIZER HELLAS S.A 243 Messogeion Ave. Neo Psychiko GR-154 51
Maltese: Neo Psychiko GR-154 51
English: therefore, in accordance with Article 83 (1)(a) of Directive 2001/82/EC, the CVMP recommends the suspension of the marketing authorisations for the veterinary medicinal products referred to in Annex I of the CVMP Opinion.
Maltese: għalhekk, skont l-Artikolu 83 (1)(a) tad-Direttiva 2001/82/KE, is-CVMP jirrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti veterinarji kollha li hemm referenza għalihom fl-Anness I għall-Opinjoni tas-CVMP.
English: These observations are further supported by data from epidemiological and laboratory studies;
Maltese: Dawn l-osservazzjonijiet jappoġġjaw aktar dejta minn studji epidemjoloġiċi u fil-laboratorju;
English: Slovak republic Pfizer Luxembourg SARL o.z.
Maltese: Pfizer Luxembourg SARL o.z. Pfizer AH Pribinova 25
English: Pfizer GmbH Linkstraße 10 D-10785 Berlin GERMANY
Maltese: Il-Ġermanja Pfizer GmbH Linkstraße 10
English: • adverse events of bovine neonatal pancytopenia reported after the use of Pregsure BVD appear to indicate an association with the product.
Maltese: • avvenimenti avversi ta' pancytopenia bovina fl-għoġġiela tat-twelid irrapportati wara l-użu ta' Pregsure BVD jidhru li jindikaw assoċjazzjoni mal-prodott.
English: France
Maltese: Paris FRANCE
English: Administration of Pregsure BVD to female cattle allows prevention of BVDV type 1 transplacental infection and the birth of BVDV type 1 persistently infected calves and laboratory scale investigations have also demonstrated that vaccination can reduce fertility losses due to BVDV type 1 infection in the early stage of gestation.
Maltese: Għoti ta' Pregsure BVD lil baqar nisa jippermetti l-prevenzjoni ta' infezzjoni transplaċentali minn BVDV tat-tip 1 u t-twelid ta' għoġġiela infettati b'mod persistenti minn BVDV tat-tip 1 u investigazzjonijiet fuq skala ta' laboratorju urew ukoll li t-tilqima tista' tnaqqas telf tal-fertilità minħabba infezzjoni minn BVDV tat-tip 1 fl-istadju bikri tal-ġestazzjoni.
English: Following the evaluation of adverse event reports of bovine neonatal pancytopenia after the use of Pregsure BVD, and epidemiological data and findings from research projects on bovine neonatal pancytopenia, the German authority (Paul-Ehrlich Institut (PEI)) questioned the benefit-risk balance for the product.
Maltese: Wara evalwazzjoni tar-rapporti tal-avvenimenti avversi ta' pancytopenia bovina fl-għoġġiela tat-twelid wara l-użu ta' Pregsure BVD, u dejta epidemjoloġika u riżultati minn proġetti ta' riċerka dwar pancytopenia bovina fl-għoġġiela tat-twelid, l-awtorità Ġermaniża (Paul-Enrich Institut (PEI)) esprimiet id-dubji tagħha dwar il-bilanċ benefiċċju-riskju għall-prodott.
English: A number of laboratory studies identified the ingestion of colostral antibodies from vaccinated dams as a potential risk factor.
Maltese: Għadd ta' studji fil-laboratorju identifikaw l-inġestjoni ta' antikorpi mill-kolostrum minn baqar imlaqqmin bħala fattur potenzjali ta' riskju.
English: The overall incidence for bovine neonatal pancytopenia events reported following use of the product was estimated to be over 0.016% across the EU, based on a single dose, between 2004 and 2009.
Maltese: L-inċidenza ġenerali għal pancytopenia bovina fl-għoġġiela tat-twelid irrapportati wara l-użu tal-prodott kienet stmata ‘l fuq minn 0.016% madwar l-UE, fuq il-bażi ta' doża waħda, bejn l-2004 u l-2009.
English: The overall incidence for bovine neonatal pancytopenia at EU level between 2004 and 2009 was estimated to be 0.016% based on a single dose.
Maltese: Linċidenza ġenerali għal pancytopenia bovina fl-għoġġiela tat-twelid fuq livell tal-UE bejn l-2004 u l2009 kienet stmata għal 0.016% fuq il-bażi ta' doża singola.
English: Bovine neonatal pancytopenia has been reported in eleven EU Member States.
Maltese: Il-pancytopenia bovina fl-għoġġiela tat-twelid ġiet irrapportata fi ħdax-il Stat Membru tal-UE.
English: PregSure BVD injekční emulze
Maltese: PregSure BVD injekční emulze l-Estonja
English: • the CVMP concluded that the benefit-risk balance for Pregsure BVD is unfavourable under the authorised conditions of use;
Maltese: • is-CVMP ikkonkluda li l-bilanċ ta' benefiċċju-riskju ta' Pregsure BVD mhuwiex wieħed favorevoli skont il-kundizzjonijiet għall-użu awtorizzati;
English: The frequency of adverse event reports with signs typical of bovine neonatal pancytopenia in herds in which Pregsure BVD was one of the vaccines used varies across affected Member States and in some Member States, e.g. Germany and United Kingdom, has increased markedly since 2009.
Maltese: Ilfrekwenza ta' avvenimenti avversi rrapportati b'sinjali tipiċi ta' pancytopenia bovina fl-għoġġiela tattwelid f'merħliet li fihom, Pregsure BVD kien wieħed mill-vaċċini użati tvarja madwar l-Istati Membri affettwati u f'xi Stati Membri, eż il-Ġermanja u r-Renju Unit, żdiedet b'mod sinifikanti mill-2009.
English: Whilst acknowledging the limitations of the pharmacovigilance data and the lack of appropriate control animals in some of laboratory studies, having evaluated the data available, the CVMP concluded the above-mentioned findings provide evidence to suggest a potential association between the occurrence of bovine neonatal pancytopenia and Pregsure BVD.
Maltese: Filwaqt li jirrikonoxxi l-limitazzjonijiet tad-dejta ta' farmakoviġilanza u n-nuqqas ta' annimali ta' kontroll xierqa f'ċerti studji fil-laboratorju, wara li evalwa d-dejta disponibbli, is-CVMP ikkonkluda li s-sejbiet imsemmijin hawn fuq jipprovdu evidenza li tissuġġerixxi assoċjazzjoni potenzjali bejn linċidenza ta' pancytopenia bovina fl-għoġġiela tat-twelid u Pregsure BVD.
English: These reports raised concern over a potential association with the use of Pregsure BVD.
Maltese: Dawn ir-rapporti qajmu tħassib dwar assoċjazzjoni potenzjali mal-użu ta' Pregsure BVD.