FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on Predicted Environmental Concentrations for surface water PECsw of 0.0005 g doramectin/l surface water (run-off scenario) and PECsw of 0.209 g doramectin/l surface water (direct excretion) an acute risk for Daphnia was identified in Tier A for both exposure scenarios with risk quotients (RQ) of 5 and 2090, respectively.
Maltese: Fuq il-bażi ta' Konċentrazzjonijiet Ambjentali Mbassra għall-ilma tal-wiċċ PECsw ta' 0.0005 g doramektina/l ilma talwiċċ (xenarju ta' skol) u PECsw ta' 0.209 g doramektina/l ilma tal-wiċċ (eskrezzjoni diretta), ġie identifikat riskju akut għal Daphnia fil-Livell A għaż-żewġ xenarji ta' espożizzjoni bi kwozjenti ta' riskju (RQ) ta' 5 u 2090, rispettivament.
English: The concentration of parent drug in faeces peaked at 3 days after administration (319 μg/kg) with a concentration of 133 µg/kg at 14 days (last sampling point).
Maltese: Il-konċentrazzjoni ta' mediċina prinċipali fir-rawt laħqet il-massimu wara 3 ijiem millamministrazzjoni (319 μg/kg) b'konċentrazzjoni ta' 133 µg/kg wara 14-il jum (l-aħħar punt ta' kampjunar).
English: Recommended dose
Maltese: Prekawzjonijiet oħra
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 għall-ambjent akwatiku twettqet fuq il-bażi ta' EC50 ta' 0.1 µg/l u NOEC ta' 0.025 derivat minn studju tat-tossiċità akuta ta' doramektina f'Daphnia (D. magna).
English: 5.3 Environmental properties
Maltese: .3 Propjetajiet ambjentali
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 10 mg/ml solution for cattle, sheep, and pigs.
Maltese: L-applikant Pfizer Limited issottometta applikazzjoni għal proċedura deċentralizzata għal Dectomax 10 mg/ml soluzzjoni għal frat, nagħaġ, u ħnieżer.
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 (RQs) for both species were high (41940 and 1405, respectively, based on the amount of total residues in dung at day 5 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 Mingħajr Effett (PNECs) derivati mill-LC50 ta' 1.34 µg/kg ħamrija għall-haematobia irritans u l-NOEC ta' 4.0 µg/kg ħamrija għall-bukagħwar (Ontophagus gazelle), il-kwozjenti ta' riskju (RQs) li rriżultaw għaż-żewġ speċi kienu għoljin (41940 u 1405, rispettivament, fuq il-bażi tal-ammont tar-residwi totali fid-demel fil-5 jum wara l-amministrazzjoni), u dan jindika riskju akut għoli għall-insetti tad-demel fil-Livell A.
English: The groups included more animals than the minimum number recommended in the withdrawal period guideline (EMEA/CVMP/036/95/final): 6 animals per groups instead of 4.
Maltese: Il-gruppi nkludew aktar annimali min-numru minimu rakkomandat fil-linja gwida dwar ilperjodu ta' tiżmim (EMEA/CVMP/036/95/final): 6 annimali f'kull grupp minflok 4.
English: The applicant provided a targeted Phase II environmental risk assessment.
Maltese: L-applikant ipprovda valutazzjoni tar-riskju ambjentali tal-Fażi II immirata.
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 endoparassiti u ektoparassiti u jista' jnaqqas in-numru ta' trattamenti bi prodotti farmaċewtiċi differenti.
English: The concentration of total doramectin residues excreted in cattle faeces peaked at 5 days after administration (562 µg/kg) and declined thereafter, accounting for 239 µg/kg at 14 days.
Maltese: Il-konċentrazzjoni tar-residwi totali tad-doramektina eliminati fil-feċi tal-ifrat laħqet il-massimu wara 5 ijiem mill-amministrazzjoni (562 µg/kg) u naqset wara dan, u ammontat għal 239 µg/kg wara 14-il jum.
English: Significant differences between studies were observed (range from 5 to 68-fold) which cannot be explained by different sample weights of injection sites.
Maltese: Ġew osservati differenzi sinifikanti bejn l-istudji (medda li tvarja bejn 5 darbiet sa 68 darba) li ma jistgħux jiġu spjegati minn kampjuni ta' piżijiet differenti tas-siti ta' injezzjoni.
English: As the risk for daphnids could not be ruled out by PEC refinements Tier B assessment should be performed according VICH Guideline 38 for which a Daphnia magna reproduction study is required.
Maltese: Peress li r-riskju għal dafnidi ma setax jiġi eliminat mill-irfinazzjonijiet tal-PEC, għandha titwettaq valutazzjoni tal-Livell B skont il-Linja Gwida 38 tal-VICH li għaliha huwa meħtieġ studju tar-riproduzzjoni ta' Daphnia magna.
English: In terms of bioaccumulation the log Pow value is not considered to be robust given the method employed (shake flask).
Maltese: F'termini ta' bijoakkumulazzjoni, il-valur tal-log Pow mhuwiex meqjus bħala robust minħabba l-metodu mħaddem (‘shake flask').
English: A GLP tissue depletion study from 1989 was performed in calves (3 groups of 4 animals) following a single subcutaneous administration of doramectin at the recommended dose of 200 µg/kg bw.
Maltese: Studju tal-użu tat-tessut tal-GLP mill-1989 twettaq fl-għoġiela (3 gruppi ta' 4 annimali) wara amministrazzjoni subkutanja waħda tad-doramektina bid-doża rakkomandata ta' 200 µg/kg bw.
English: Several studies and published literature on the toxicity to dung fauna were available.
Maltese: Għad-dispożizzjoni kien hemm bosta studji u letteratura ppubblikata dwar it-tossiċità għall-fawna taddemel.
English: Romania
Maltese: Rumanija
English: It protects pigs against infection or reinfection with Sarcoptes scabiei for 18 days.
Maltese: Jipproteġi lill-ħnieżer kontra infezzjoni jew infezzjoni millġdid b'Sarcoptes scabiei għal 18-il jum.
English: Kidney: 60 μg/kg
Maltese: Kilwa: 60 μg/kg
English: The reference products for this generic application were Dectomax 1% w/v solution for injection for cattle and sheep and Dectomax 10 mg/ml solution for injection for pigs.
Maltese: Il-prodotti ta' referenza għal din l-applikazzjoni ġenerika kienu Dectomax 1% w/v soluzzjoni għal injezzjoni għal frat u nagħaġ u Dectomax 10 mg/ml soluzzjoni għal injezzjoni għal ħnieżer.
English: The study is not in accordance with the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95/final) and the guideline on injection site residues (EMEA/CVMP/542/03-FINAL) as the injection site was not sampled as recommended in the current guideline (i.e. with a separate core plus its surrounding tissue).
Maltese: L-istudju ma sarx skont in-Nota tas-CVMP għal gwida dwar l-approċċ lejn armonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95/final) u l-linja gwida dwar ir-residwi fis-sit ta' injezzjoni (EMEA/CVMP/542/03-FINAL) peress li s-sit ta' injezzjoni ma ġiex kampjunat kif rakkomandat fil-linja gwida attwali (jiġifieri b'qalba separata flimkien mat-tessut imdawwar magħha).
English: A GLP tissue depletion study from 2002 performed in cattle (34 animals) following two subcutaneous administrations of doramectin at the recommended dose of 200 µg/kg bw with an interval of 7 days between doses.
Maltese: Studju ta' użu tat-tessut tal-GLP mill-2002 imwettaq fl-ifrat (34 annimal) wara żewġ amministrazzjonijiet subkutanji tad-doramektina bid-doża rakkomandata ta' 200 µg/kg bw b'intervall ta' 7 ijiem bejn id-dożi.
English: According to the VICH Guideline 38 Phase II, a Tier B assessment is required.
Maltese: Skont il-Linja Gwida 38 tal-VICH, hija meħtieġa valutazzjoni tal-Fażi II, Livell B.
English: In cattle, the product is intended for the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, warbles, lice and mange mites.
Maltese: Fl-ifrat, il-prodott huwa maħsub għat-trattament u l-kontroll ta' dud nematode gastrointestinali, dud nematode tal-pulmun, loa loa, mard tal-ipoderma, qamel u mange mites.
English: Liver: 100 μg/kg
Maltese: Fwied: 100 μg/kg
English: This results in a withdrawal period of 70 days.
Maltese: Dan jirriżulta f'perjodu ta' tiżmim ta' 70 jum.
English: Conclusions on the benefit-risk balance
Maltese: Valutazzjoni tar-riskju ambjentali
English: The following text should be included in section 5.3 of the SPC (environmental properties):
Maltese: It-test li ġej għandu jiġi inkluż fis-sezzjoni 5.3 tal-SPC (Proprjetajiet ambjentali):
English: Consequently the matter was referred to the CVMP.
Maltese: G]aldaqstant il-kwistjoni ġiet riferuta lis-CVMP.
English: SHEEP: Meat and offal: - withdrawal period: 63 days.
Maltese: NAGĦAĠ: : Laħam u ġewwieni: - perjodu ta' tiżmim: 63 jum.
English: Further PEC refinement for the direct excretion scenario considering that peak excretion of total residues occurred on day 5 after administration and accounted for 7.8% of the administered dose, as well as based on sediment partitioning lead to a PECsw-refined-direct of 0.00049 µg/l, resulting in a RQ for Daphnia (4.9) still higher than 1.
Maltese: Irfinar ulterjuri tal-PEC għax-xenarju ta' eskrezzjoni diretta li jikkunsidra li l-ogħla livell ta' eskrezzjoni tar-residwi totali seħħ fil-jum 5 wara l-amministrazzjoni u ammonta għal 7.8% tad-doża amministrata, kif ukoll fuq il-bażi ta' diviżjoni tan-naqal iwasslu għal PECsw-irfinati-diretti ta' 0.00049 µg/l, li jirriżultaw f'RQ għal Daphnia (4.9) li jibqa' ogħla minn 1.
English: PIGS: Meat and offal:withdrawal period 56 days..
Maltese: ĦNIEŻER: Laħam u ġewwieni: - perjodu ta' tiżmim: 56 jum.
English: Benefits have not been subject of this referral; they were considered in the preceding decentralised procedure.
Maltese: Il-benefiċċji ma kinux is-suġġett ta' din il-konsultazzjoni; ġew ikkunsidrati fil-proċedura deċentralizzata preċedenti.
English: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs contains doramectin as active ingredient.
Maltese: Prontax 10 mg/ml soluzzjoni għal frat, nagħaġ u ħnieżer fih is-sustanza attiva doramektina.
English: The potential serious risks regarding the environment identified by France and the Netherlands are risks to dung fauna and Daphnia magna in accordance with the proposed instructions for use and a risk identified by the Netherlands due to the bioaccumulation potential linked to the determination of the log KOW by using a test method, which was not considered appropriate for the active ingredient.
Maltese: Ir-riskji serji potenzjali rigward l-ambjent identifikati minn Franza u l-Pajjiżi l-Baxxi huma riskji għallfawna tad-demel u Daphnia magna skont l-istruzzjonijiet proposti għall-użu u riskju identifikat millPajjiżi l-Baxxi minħabba l-potenzjal ta' bijoakkomulazzjoni marbut mad-determinazzjoni tal-log KOW billi jintuża metodu ta' ttestjar, li ma tqiesx xieraq għas-sustanza attiva.
English: A GLP tissue depletion study from 1991 was performed in calves (18 animals) following a single subcutaneous administration of doramectin at the recommended dose of 200 µg/kg bw.
Maltese: Twettaq studju tal-użu tat-tessut tal-GLP mill-1991 fl-għoġġiela (18-il annimal) wara amministrazzjoni subkutanja waħda tad-doramektina bid-doża rakkomandata ta' 200 µg/kg bw.
English: Injection sites at 35 and 56 days were not assayed.
Maltese: Ma ġewx mixtarra s-siti ta' injezzjoni fil-35 u s-56 jum.
English: The risk characterisation for dung fauna was performed using Predicted Environmental Concentrations (PECs) for dung, which were derived using the metabolism study provided.
Maltese: Il-karatterizzazzjoni tar-riskji għall-fawna tad-demel twettqet billi ntużaw Konċentrazzjonijiet Ambjentali Mbassra (PECs) għad-demel, li ġew derivati billi ntuża l-istudju tal-metaboliżmu pprovdut.
English: In absence of data, it is proposed that the risk to dung fauna from sheep dung should be viewed as similar to the risk arising from treatment of cattle.
Maltese: Fin-nuqqas ta' dejta, huwa propost li r-riskju għall-fawna tad-demel minn demel tan-nagħaġ għandu jitqies bħala simili għar-riskju li jirriżulta mit-trattament tal-ifrat.
English: In terms of environmental safety, in addition to the fact that the current data package does not allow to rule out bioaccumulation of doramectin, a risk to the aquatic compartment has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung when the product is used in accordance with the recommended posology.
Maltese: F'termini ta' sikurezza ambjentali, minbarra l-fatt li l-pakkett ta' dejta attwali ma jeliminax ilpossibbiltà ta' bijoakkumulazzjoni tad-doramektina, ġie identifikat riskju għall-kompartiment akwatiku fuq il-bażi ta' dejta disponibbli dwar it-tossiċità (tossiċità akuta għal Daphnia magna) kif ukoll riskju għal fawna tad-demel esposta għal demel li fih residwu meta l-prodott jintuża skont il-pożoloġija rakkomandata.
English: After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, it was concluded that aquatic organisms were not at risk from doramectin entering surface water bodies via run-off.
Maltese: Wara rfinar tal-PECsw permezz tal-mudell FOCUS kif irrakkomandat mil-linja gwida CVMP/ERA/418282/2005 tas-CVMP, ġie konkluż li l-organiżmi akwatiċi ma kinux firriskju li d-doramektina tidħol fil-korpi tal-ilma tal-wiċċ permezz ta' skol.
English: No data on the nature and rates of metabolites are available.
Maltese: Ma hija disponibbli l-ebda dejta dwar in-natura u r-rati ta' metaboliti.
English: The CVMP considered that the test method for the determination of the n-octanol/water partition coefficient was not appropriate.
Maltese: Is-CVMP qies li l-metodu ta' ttestjar għad-determinazzjoni tal-koeffiċjent tal-partizzjoni n-octanol/ilma ma kienx xieraq.
English: For the run-off scenario, as the highest PECcattle (0.84 µg/kg) is higher than the highest PECsheep (0.48 µg/kg), the conclusion from the cattle can be extrapolated to sheep.
Maltese: Għax-xenarju ta' skol, peress li l-ogħla PECfrat (0.84 µg/kg) huwa ogħla mill-ogħla PECnagħaġ (0.48 µg/kg), ilkonklużjoni għall-ifrat tista' tiġi estrapolata għan-nagħaġ.
English: CATTLE:
Maltese: Billi:
English: Fat: 150 μg/kg
Maltese: Xaħam:150 μg/kg
English: Iceland
Maltese: Iżlanda
English: The following text is proposed in section 4.5 (special precautions for use):
Maltese: It-test li ġej huwa propost fis-sezzjoni 4.5 (prekawzjonijiet speċjali għall-użu):
English: In sheep, the product is intended for the treatment and control of Psoroptes ovis (sheep scab mite) and for the treatment and control of gastrointestinal roundworms and nasal bots.
Maltese: Fin-nagħaġ, il-prodott huwa maħsub għat-trattament u l-kontroll ta' Psoroptes ovis (akari tal-qxur finnagħaġ) u għat-trattament u l-kontroll tad-dud nematode gastrointestinali u l-qurdien nażali.
English: 4.5 Special precaution for use
Maltese: 4.5 Prekawzjonijiet Speċjali għall-Użu
English: The benefit-risk evaluation is deemed to be positive provided that (1) the recommended risk mitigation measures are added to the product literature regarding risk to aquatic organisms and dung fauna and (2) the withdrawal period for meat and offal in cattle should be set at 70 days.
Maltese: Il-valutazzjoni bejn il-benefiċċji u r-riskji hija meqjusa pożittiva jekk (1) jiżdiedu l-miżuri rakkomandati ta' mitigazzjoni tar-riskju mal-letteratura tal-prodott rigward ir-riskju għall-organiżmi akwatiċi u lfawna tad-demel u (2), il-perjodu ta' rtirar għall-laħam u l-ġewwieni tal-ifrat għandu jitfassal għal 70 jum.
English: A non-GLP tissue depletion study from 2003 was performed in cattle (24 animals) following a single subcutaneous administration of doramectin at the recommended dose of 200 µg/kg bw.
Maltese: Sar studju ta' użu tat-tessut mhux tal-GLP fl-ifrat (24 annimal) wara amministrazzjoni subkutanja waħda tad-doramektina bid-doża rakkomandata ta' 200 µg/kg bw.
English: It is a macrocyclic lactone and is closely related to ivermectin.
Maltese: Huwa latton makroċikliku u huwa relatat mill-qrib mal-ivermektina.
English: Two Concerned Member States (the Netherlands and France) considered that the authorisation of Prontax 10 mg/ml solution for injection for cattle, sheep, and pigs may present a potential serious risk to the environment and risk to the consumer.
Maltese: Żewġ Stati Membri Kkonċernati (il-Pajjiżi l-Baxxi u Franza) qiesu li l-awtorizzazzjoni ta' Prontax 10 mg/ml soluzzjoni għal injezzjoni għal frat, nagħaġ, u ħnieżer tista' tippreżenta riskju serju potenzjali għall-ambjent u riskju għall-konsumaturi.
English: Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks.
Maltese: Wara t-trattament, jista' jkum hemm eliminazzjoni ta' livelli potenzjalment tossiċi ta' doramectin fuq perjodu ta' ħafna ġimgħat.
English: A withdrawal period of 63 days has been established for cattle for the reference product.
Maltese: Għall-ifrat, ġie stabbilit perjodu ta' tiżmim ta' 63 jum għall-prodott ta' referenza.
English: It is noted that the study (2002) predates the introduction of that guideline (2005).
Maltese: Ġie osservat li listudju (2002) sar kronoloġikament qabel l-introduzzjoni ta' dik il-linja gwida (2005).
English: This summary was last updated in 11-2006.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 11-2006.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EURICAN HERPES 205 EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) EURICAN HERPES 205 Sommarju ta' l-EPAR għall-pubbliku
English: Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 µg.
Maltese: Eurican Herpes 205 fih issustanza attiva antiġen tal-virus tal-ħerpes tal-klieb (razza F205) f'doża ta' 0.3 sa 1.75 µg.
English: Eurican Herpes 205 contains mineral oil.
Maltese: Eurican Herpes 205 fih żejt minerali.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The last one has demonstrating that induction of antibodies is equivalent when bitches are vaccinated the day of heat or 7-10 days after mating.
Maltese: L-aħħar wieħed wera li linduzzjoni ta' antikorpi hija ekwivalenti meta l-klieb nisa jitlaqqmu dakinhar li jkunu sħan jew 7-10 ijiem wara d-data tat-tgħammir.
English: The benefitrisk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jista' jinstab fil-modulu 6 ta' dan l-EPAR.
English: Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life.
Maltese: Eurican Herpes 205 jintuża għall-immunizzazzjoni ta' klieb nisa għall-prevenzjoni ta' mortalità, sinjali kliniċi u feriti fi ġriewi kkawżati minn infezzjonijiet bil-virus tal-ħerpes tal-klieb akkwistat flewwel ftit jiem ta' ħajja.
English: What are the side effects of Eurican Herpes 205?
Maltese: X'inhuma l-effetti sekondarji ta' Eurican Herpes 205?
English: In one field trial the serological response (antibody production) was measured.
Maltese: Fi prova klinika, ġie mkejjel ir-rispons seroloġiku (produzzjoni ta' antikorpi).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni tal-kummerċ valida madwar l-Unjoni Ewropea kollha, għal Eurican Herpes 205 lil Merial fis-26 ta' Marzu 2001.
English: The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals.
Maltese: L-injezzjoni ta' Eurican Herpes 205 tista' tikkawża edema temporanja (fluwidi taħt il-ġilda) fis-sit ta' l-injezzjoni f'sa 10% ta' l-annimali.
English: What is Eurican Herpes 205?
Maltese: X'inhu Eurican Herpes 205?
English: Eurican Herpes 205 has been studied in three laboratory studies and two field trials.
Maltese: Eurican Herpes 205 ġie studjat fi tliet studji tal-laboratorju u f'żewġ provi kliniċi.
English: Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection.
Maltese: Eurican Herpes 205 huwa trab u solvent li jsir emulsjoni għal injezzjoni.
English: Other information about Eurican Herpes 205:
Maltese: Tagħrif ieħor dwar Eurican Herpes 205:
English: Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses.
Maltese: Eurican Herpes 205 jingħata bħala żewġ dożi subkutanji (taħt il-ġilda) ta' 1 ml kull waħda.
English: When injected, this small exposure helps the dog's immune system to synthesize antibodies against the canine herpes virus and to neutralize it. Once vaccinated, bitches will, through colostrum, give those antibodies to puppies.
Maltese: Meta injettat, din lespożizzjoni żgħira tgħin lis-sistema immuni tal-kelb sabiex tissintezzizza antikorpi kontra l-virus talħerpes tal-klieb u biex tinnewtralizzah.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l-benefiċċji ta' Eurican Herpes 205 huma akbar minn kwalunkwe riskju li t-tilqima għall-klieb nisa b'saħħithom jista' jkollha kontra l-virus tal-ħerpes tal-klieb.
English: Why has Eurican Herpes 205 been approved?
Maltese: Għaliex Eurican Herpes 205 ġie approvat?
English: Here Eurican Herpes 205 was compared with no vaccination (controls).
Maltese: Hawnhekk, Eurican Herpes 205 tqabbel mingħajr tilqim (kontrolli).
English: Eurican Herpes 205 contains small amounts of canine herpes virus antigens.
Maltese: Eurican Herpes 205 fih ammonti żgħar ta' antiġens tal-virus tal-ħerpes tal-klieb.
English: Eurican Herpes 205 showed good protection from canine herpes virus.
Maltese: Eurican Herpes 205 wera protezzjoni tajba kontra l-virus tal-ħerpes tal-klieb.
English: The first injection is given either when the bitch is on heat or 7 -10 days after the date of mating.
Maltese: L-ewwel injezzjoni tingħata jew meta l-kelba tkun sħuna jew 7 - 10 ijiem wara d-data tat-tgħammir.
English: In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived..
Maltese: Fl-istudju għall-wiri talprotezzjoni tal-ġriewi (minn klieb nisa mlaqqmin) mill-virus tal-ħerpes tal-klieb, għexu aktar minn 80% tal-ġriewi mill-klieb nisa mlaqqmin.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR).
English: Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.
Maltese: Eurican Herpes 205 huwa maħsub sabiex jipproteġi l-ġriewi kontra din l-infezzjoni matul l-ewwel jiem ta' ħajjithom.
English: Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.
Maltese: F'każijiet rari, jista' jkun hemm reazzjonijiet (allerġiċi) ta' sensittività eċċessiva li jistgħu jkunu jeħtieġu trattament.
English: This side effect usually disappears within one week.
Maltese: Dan l-effett sekondarju normalment jisparixxi fi żmien ġimgħa.
English: 09 October 2013
Maltese: 09 Ottubru 2013
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 29 tad-Direttiva 2001/83/KE
English: EMA/444197/2013 rev. 1 EMEA/H/A-29/1359
Maltese: 1 EMEA/H/A-29/1359
English: Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet 18, 36 and 54 mg) EMA/444197/2013 rev.1
Maltese: pillola li terħi l-mediċina bil-mod, 18, 36 u 54 mg) EMA/444197/2013 rev.1