FrancophonIA/ELRC3.0 huggingface dataset:
English: Calcium supplements, antacids and some oral medicinal products containing multivalent cations Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bondenza.
Maltese: Supplimenti tal-kalċju, antaċidi u xi prodotti mediċinali li jittieħdu mill-ħalq li fihom ketajins multivalenti (bħall-aluminju, l-magneżju u l-ħadid) x'aktarx li jinterferixxu mal-assorbiment ta' Bondenza.
English: Children and adolescents Do not give Bondenza to children or adolescents below 18 years.
Maltese: Tfal u adolexxenti Tagħtix Bondenza lil tfal jew adolexxenti b'età inqas minn 18-il sena.
English: Two year data in study BM 16550
Maltese: Tagħrif ta' wara sena fl-istudju BM 16550
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' ibandronic acid (bħala sodium monohydrate).
English: White to off white film-coated tablets, of oblong shape marked “BNVA” on one side, and “150” on the other side.
Maltese: Pilloli bojod sa fl-offwajt miksija b'rita, b'forma oblung immarkati “BNVA” fuq naħa u “150” fuq innaħa l-oħra.
English: There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Maltese: Ma hemm l-ebda evidenza ta' xi differenza ta' relevanza klinika bejn ir-razez bejn l-Ażjatiċi u lKawkasi fid-disposizjoni ta' ibandronic acid.
English: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Maltese: Kura ta' l-osteoporożi fin-nisa f'riskju akbar ta' ksur wara l-menopawża (ara sezzjoni 5.1).
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
Maltese: • sintomi jixbħu lill-influwenza, inkluż deni, tregħid u tertir, sensazzjoni ta' skomdu, għeja, uġigħ fl-għadam u uġigħ fil-muskoli u l-ġogi.
English: The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2 % in the 3 mg injection every 3 months arm and 67.2 % in the 2.5 mg daily orally arm (p=0.007).
Maltese: Il-proporzjon ta' pazjenti li żiedu jew żammew il-BMD tagħhom wara sena kemm fis-sinsla lumbari kif ukoll fil-ġembejn totali kien ta' 76.2 % fil-grupp ta' injezzjoni ta' 3 mg kull 3 xhur u 67.2 % filgrupp ta' 2.5 mg orali kuljum (p=0.007).
English: Pharmacovigilance Plan or risk minimisation activities
Maltese: Sigurtà, il-Pjan ta' Farmakoviġilanza jew l-attivitajiet ta' minimizzazzjoni tar-riskju
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Maltese: Fi studji dwar l-effett fuq is-sistema riproduttiva fuq il-firien b'għoti fil-vina, ibandronic acid naqqas l-għadd tal-isperma b'dożi ta' 0.3 u 1 mg/kg/kuljum u naqqas il-fertilità fl-irġiel b'1 mg/kg/kuljum u fin-nisa b'1.2 mg/kg/kuljum.
English: Elderly population (see section 4.2)
Maltese: Popolazzjoni anzjana (ara sezzjoni 4.2)
English: NAME OF THE MEDICINAL PRODUCT Bondenza 3 mg solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Bondenza 3 mg soluzzjoni għall-injezzjoni
English: Bondenza 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Maltese: Bondenza 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bħal bisphosphonates oħra mogħtija ġol-vini, jista' jikkawża tnaqqis temporanju fil-valuri ta' kalċju fis-serum.
English: Due to limited clinical experience, Bondenza is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Maltese: Minħabba esperjenza klinika limitata, Bondenza mhux irrakkomandat għal pazjenti bi tneħħija talkrejatinina taħt 30ml/min (ara sezzjoni 5.2).
English: • feeling weak
Maltese: • tħossok debboli
English: One year data in study BM 16549 Two year data in study BM 16549
Maltese: III BM16549 u MF4411 u wara t-tqegħid fis-suq.
English: Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Maltese: Ibandronic acid iwassal għal żidiet progressivi netti fil-massa ta' lgħadam u għall-inċidenza mnaqqsa ta' ksur billi jnaqqas it-tibdil elevat ta' l-għadam lejn livelli ta' qabel il-menopawża f'nisa wara l-menopawża.
English: In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20 %, probably as a result of reduced gastric acidity.
Maltese: F'voluntiera maskili b'saħħithom u f'nisa wara l-menopawża, l-għoti ta' ranitidine minn ġol-vina ikkawża żjieda ta' madwar 20% fil-bijodisponibiltà ta' ibandronic acid probabbilment bħala riżultat ta' tnaqqis ta' l-aċidità gastrika.
English: Ibandronic acid was taken 60 minutes before the first food or drink of the day (post-dose fasting period).
Maltese: Ibandronic acid ttieħed 60 minuta qabel l-ewwel ikel jew xorb tal-ġurnata (perijodu ta' sawn ta' wara d-doża).
English: At two years 93.4 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Maltese: Mat-tieni sena 93.4 % (p<0.001) tal-pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix-xahar u 78.4 %, tal-pazjenti li kienu qed jirċievu ibandronic acid 2.5 mg kuljum kellhom żieda fil-BMD totali tal-ġembejn 'l fuq jew daqs il-linja bażi.
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50 - 60 % of total clearance, and is related to creatinine clearance.
Maltese: It-tneħħija mill-kliewi (madwar 60 ml/min f'nisa b'saħħithom wara l-menopawża) tkopri 50 - 60% tat-tneħħija totali u hija relatata mat-tneħħija tal-krejatinina.
English: Bondenza 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Maltese: Bondenza 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest għandha tiġi njettata ġol-vini fuq perjodu ta' 15 - 30 sekonda.
English: - If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondenza.
Maltese: - Jekk qiegħed taħt kura dentali jew ser tagħmel kirurġija dentali, għarraf lid-dentist tiegħek li qed tiġi kkurat b'Bondenza.
English: Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet - smoking, or drinking too much alcohol - not enough walking or other weight-bearing exercise - a family history of osteoporosis
Maltese: Affarijiet oħra li jistgħu jżidu r-riskju ta' ksur jinkludu: - insuffiċjenza ta' kalċju u vitamina D fid-dieta - tipjip, jew xorb ta' alkoħol żejjed - mhux biżżejjed mixi jew eżerċizzju ieħor ta' rfigħ ta' piżijiet - passat mediku ta' osteoporożi fil-familja
English: The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Maltese: Il-farmakokinetika ta' ibandronic acid f'pazjenti b'marda talkliewi ta' l-aħħar stadju kienet stmata biss f'numru żgħir ta' pazjenti immaniġġjati b'emodijalisi, għalhekk il-farmakokinetika ta' ibandronic acid f'pazjenti mhux fuq emodijalisi mhux magħrufa.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Maltese: Listudju involva nisa b'età minn 55 sa 80 sena, li kienu mill-inqas 5 snin wara l-menopawża u li kellhom BMD fis-sinsla lumbari ta' -2 sa -5
English: No indication of carcinogenic potential was observed.
Maltese: Ma ġiet osservata l-ebda indikazzjoni ta' potenzjal karċinoġeniku.
English: See the package leaflet for further information.
Maltese: Jista jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4) .
Maltese: Minħabba li l-esperjenza klinika hija limitata, Bondenza mhux rakkomandat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 4.2 u sezzjoni 4.4).
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 - Hypocalcaemia
Maltese: - Sensittività eċċessiva għal ibandronic acid jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Ipokalċimja.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Maltese: L-assorbiment ta' ibandronic acid fil-parti ta' fuq tas-sistema gastro-intestinali iseħħ malajr wara għoti mill-ħalq u l-konċentrazzjonijiet fil-plażma jiżdiedu proporzjonalment mad-doża sa 50 mg ta' teħid orali, b'żjiediet akbar milli proporzjonalment mad-doża osservati 'l fuq minn din id-doża.
English: Lumbar spine L2-L4 BMD 3.9 [3.4, 4.3]
Maltese: Sinsla lumbari L2-L4
English: After swallowing your monthly Bondenza tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Maltese: Wara li tibla l-pillola tiegħek ta' kull xahar ta' Bondenza, stenna għal siegħa qabel tieħu xi mediċina oħra, inkluż pilloli għall-indiġestjoni, supplimenti ta' kalċju, jew vitamini.
English: - Take one Bondenza 150 mg tablet once a month.
Maltese: - Ħu pillola waħda ta' Bondenza 150 mg darba fix-xahar.
English: Bondenza 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Maltese: Fi studju ta' ħafna ċentri, double-blind, ta' sentejn (BM 16549) ta' nisa wara l-menopawża b'osteoporożi (punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/266/005
English: Bondenza may help lower the chances of breaking bones (fractures).
Maltese: Bondenza jista' jgħin inaqqas ir-riskju ta' ksur ta' għadam (fratturi).
English: Both daily, intermittent (with a dose-free interval of 9 - 10 weeks per quarter) oral doses as well as intravenous doses of ibandronic acid in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption.
Maltese: Kemm dożi orali, intermittenti ta' kuljum, (b'intervall mingħajr doża ta' 9 - 10 ġimgħat kull kwart) kif ukoll dożi ġol-vini ta' ibandronic acid f'nisa wara l-menopawża ipproduċew bidliet biokimiċi li jindikaw inibizzjoni dipendenti mid-doża ta' assorbmient mill-ġdid ta' l-għadam.
English: Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Maltese: Reazzjonijiet avversi oħra għal ibandronic acid fi studji tat-tossiċità riproduttiva fil-far kienu dawk osservati bil-bisphosphonates bħala klassi.
English: Roche Farma, S.A. Tel: +34 - 94 481 83 00
Maltese: Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Maltese: Meta jkun ikkunsidrat kriterju aktar strett, li jikkombina kemm il-BMD tas-sinsla lumbari kif ukoll ilBMD totali tal-ġembejn, 83.9 % (p<0.001) u 65.7 % tal-pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum, rispettivament, kienu dawk li rrispondew ma' l-ewwel sena.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Maltese: Listudju involva nisa b'età minn 55 sa 80 sena, li kienu mill-inqas 5 snin wara l-menopawża u li kellhom BMD fis-sinsla lumbari ta' 2 sa 5
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Maltese: Ir-riskju ta' esperjenzi avversi esofagali severi jidher li huwa akbar f'pazjenti li ma jsegwux l-istruzzjoni tad-dożaġġ u/jew li jkomplu jieħdu bisphosphonates orali wara li jiżviluppaw sintomi li jissuġġerixxu irritazzjoni esofagali.
English: Biotransformation There is no evidence that ibandronic acid is metabolised in animals or humans.
Maltese: Bijotrasformazzjoni M'hemm l-ebda evidenza li ibandronic acid huwa metabolizzat fl-annimali jew fil-bnedmin.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet ta' farmakovigilanza kif deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu maqbul fil-RMP ippreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP).
English: • persistent eye pain and inflammation (if prolonged)
Maltese: • uġigħ u infjammazzjoni persistenti fl-għajn (jekk għal tul ta' żmien)
English: - Tablets should be swallowed whole with a glass of water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Maltese: - Il-pilloli għandhom jinbelgħu sħaħ ma' tazza ilma (180 sa 240 ml) waqt li l-pazjent ikun bilqiegħda jew bilwieqfa f'pożizzjoni dritta.
English: NAME OF THE MEDICINAL PRODUCT Bondenza 150 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Bondenza 150 mg pilloli miksija b'rita.
English: Use the peel-off stickers below to mark the dates on your calendar.
Maltese: Uża t-tikketti li jitqaxxru taħt biex timmarka d-dati fuq il-kalendarju tiegħek.
English: Film-coated tablet
Maltese: NUMRU TAL-LOTT LOTT
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Maltese: Bisphosphonates mogħtija mill-ħalq jistgħu jikkawżaw irritazzjoni lokali tal-mukuża tal-apparat gastro-intestinali ta' fuq.
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bondenza 3 mg injection.
Maltese: Dehru ukoll tnaqqis mistenni fil-bidla ta' l-għadam, kwalità normali ta' l-għadam u nuqqas ta' difetti filmineralizzazjoni wara sentejn ta' kura b'injezzjoni ta' Bondenza 3 mg.
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Bondenza.
Maltese: Waqt kura bil-bisphosphonate il-pazjenti għandhom jiġu mwissija biex jirrappurtaw kwalunkwe uġigħ fil-koxxa, fil-ġenbejn jew fl-irqiq ta' bejn iż-żaqq u l-koxxa u kull pazjent li jkollu sintomi bħal dawn għandha ssirlu evalwazzjoni għal ksur mhux komplut tal-għadma tal-wirk.
English: Early plasma levels fall quickly, reaching 10 % of the peak values within 3 and 8 hours after intravenous or oral administration, respectively.
Maltese: Livelli bikrija fil-plażma jinżlu malajr u jilħqu 10% tal-valuri massimi fi 3 u 8 sigħat wara għoti minn ġol-vina jew mill-ħalq rispettivament.
English: Physicians should be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue Bondenza and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Maltese: It-tobba għandhom joqgħodu attenti għal xi sinjali jew sintomi li jindikaw il-possibbiltà ta' reazzjoni esofagali u l-pazjenti għandhom jiġu mgħallma biex iwaqqfu Bondenza u jfittxu attenzjoni medika jekk jiżviluppaw disfaġija, odinofaġija, uġigħ retrosternali jew ħruq ta' stonku ġdid jew li rkada.
English: One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as sodium monohydrate).
Maltese: Siringa waħda mimlija għal-lest fiha 3 mg ta' ibandronic acid f'3 ml ta' soluzzjoni (bħala sodium monohydrate).
English: • serious, potentially life-threatening allergic reaction
Maltese: • reazzjoni allerġika serja, li tista' tkun fatali
English: • serious, potentially life-threatening allergic reaction (see section 2).
Maltese: • reazzjoni allerġika serja, li tista' tkun fatali (ara sezzjoni 2).
English: Continuing to take Bondenza
Maltese: Kompli irċievi Bondenza
English: Date of latest renewal: 20.02.2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23.02.2004
English: Kent CT13 9NJ United Kingdom
Maltese: Kent CT13 9NJ
English: Denmark Pfizer Limited Veterinary Medical Research &
Maltese: Danimarka Pfizer Limited Veterinary
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia and Sweden.
Maltese: L-Istati Membru ta' referenza kien l-Irlanda u l-Istati Membri Kkonċernati kienu l-Awstrija, il-Bulgarjia, id-Danimarka, Spanja, il-Finlandja, Franza, l-Ungerija, lIslanda, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovenja u l-Isvezja.
English: The product has claims for persistent efficacy ranging from 21 to 49 days.
Maltese: Ġie ddikkjarat li l-prodott għandu effikaċja persistenti li tvarja bejn 21 u 49 jum.
English: The application has been presented in accordance with Article 13(1) of Directive 2001/82/EC as amended, i.e. it is a generic application.
Maltese: L-applikazzjoni ġiet ippreżentata skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE kif emendata, jiġifieri hija applikazzjoni ġenerika.
English: The parent drug accounted for 79% of the total radioactive faecal residue.
Maltese: Il-mediċina prinċipali ammontat għal 79% tar-residwu totali radjuattiv fil-feċi.
English: Doramectin is an antipatasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Maltese: Id-doramektina hija sustanza antiparasitika, iżolata mill-fermentazzjoni ta' razez magħżula derivati mill-organiżmu tal-ħamrija Streptomyces avermitilis.
English: The application was submitted in accordance with the Article 13(1) of the Directive 2001/82/EC (i.e. an application for a generic product).
Maltese: Lapplikazzjoni tressqet skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE (jiġifieri applikazzoni għal prodott ġeneriku).
English: Prontax 5 mg/ml pour-on solution for cattle contains doramectin as active ingredient.
Maltese: Prontax 5 mg/ml soluzzjoni li titferragħ għall-ifrat li fiha s-sustanza attiva doramektina.
English: Based on Predicted Environmental Concentrations (PEC) for surface water PECsw of 0.0026 µg doramectin/l surface water (run-off scenario) and PECsw of 0.5225 µg doramectin/l surface water (direct excretion) an acute risk for Daphnia was identified in Tier A for both exposure scenarios with PEC/PNEC risk quotients (RQ) of 26 and 5225, respectively.
Maltese: Fuq il-bażi talKonċentrazzjonijiet Ambjentali Mbassra (PEC) għall-ilma tal-wiċċ PECsw ta' 0.0026 µg doramektina/l ilma tal-wiċċ (xenarju ta' skol) u PECsw ta' 0.5225 µg doramektina/l ilma tal-wiċċ (eskrezzjoni diretta), fil-Livell A ġie identifikat riskju akut għal Daphnia għaż-żewġ xenarji ta' espożizzjoni bi kwozjenti tarriskju PEC/PNEC (RQ) ta' 26 u 5225, rispettivament.
English: Based on the Predicted No Effect Concentrations (PNECs) derived from the LC50 of 1.34 µg/kg soil for horn flies (Haematobia irritans) and the NOEC of 4.0 µg/kg soil for dung beetles (Ontophagus gazelle) the resulting risk quotients for both species were high (20149 and 675, respectively, based on the amount of total residues in dung at day 21 after administration), indicating a high acute risk to dung insects in Tier A. Consequently a Tier B assessment should be performed.
Maltese: Fuq il-bażi tal-Konċentrazzjonijiet Imbassra Bla Effett (PNECs) miġjuba minn LC50 ta' 1.34 µg/kg ħamrija għall-Haematobia irritans u NOEC ta' 4.0 µg/kg ħamrija għall-bukagħwar (Ontophagus gazelle), il-kwozjenti tar-riskju li rriżultaw għaż-żewġ speċi kienu għoljin (20149 u 675, rispettivament, fuq il-bażi tal-ammont tar-residwi totali fid-demel wara 21 jum mill-amministrazzjoni), u dan jindika riskju akut għoli għall-insetti tad-demel fil-Livell A.
English: Withdrawal periods
Maltese: Doża rrakkomandata
English: The risk characterisation for the aquatic environment was conducted based on an EC50 of 0.1 µg/l and a NOEC of 0.025 derived from an acute toxicity study of doramectin in Daphnia (D. magna).
Maltese: Il-karatterizzazzjoni tar-riskju ghall-ambjent akwatiku twettqet fuq il-bazi ta' EC50 ta' 0.1 µg/l u NOEC ta' 0.025 derivat minn studju tat-tossiċità akuta tad-doramektina f'Daphnia (D. magna).
English: Elanco Animal Health, Eli Lilly and Company Limited and the name of the reference product in
Maltese: Pfizer Healthcare Ireland għal Elanco Animal Health, Eli Lilly and Company Limited u l-isem tal prodott ta' referenza fl-Irlanda nbidel għal Zearl 5 mg/ml soluzzjoni li titferragħ għall-ifrat.
English: The product has dual action against endo- and ecto-parasites and may reduce the number of treatments with different pharmaceutical products.
Maltese: Il-prodott għandu azzjoni doppja kontra l-endoparassiti u l-ektoparassiti u jista' jnaqqas in-numru ta' trattamenti bi prodotti farmaċewtici differenti.
English: An ERA was performed by the applicant in accordance with the VICH guidelines for Phase I and Phase II assessment adopted by the CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) as well as the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH Guidelines GL6 and GL38 (CVMP/ERA/418282/2005-corr).
Maltese: Twettqet ERA mill-applikant skont il-linji gwida tal-VICH għall-valutazzjoni tal-Fażi I u l-Fażi II adottati mis-CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) kif ukoll il-linja gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għall-Prodotti Mediċinali Veterinarji b'appoġġ għal-Linji
English: After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, the RQ remains above 1 for Daphnia.
Maltese: Gwida talVICH GL6 u GL38 (CVMP/ERA/418282/2005-corr).
English: Risk assessment
Maltese: Research &
English: The concentration of total doramectin residues excreted in cattle faeces peaked at 21 days after administration (270 µg/kg) and declined thereafter, accounting for 52 µg/kg at 35 days and 3.9 µg/kg at 56 days.
Maltese: Ilkonċentrazzjoni tar-residwi totali tad-doramektina eliminati fil-feċi tal-ifrat laħqu l-massimu 21 jum wara l-amministrazzjoni (270 µg/kg) u wara dakinhar naqsu, u ammontaw għal 52 µg/kg fil-35 jum u 3.9 µg/kg fis-56 jum.