FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH did not agree with the PhVWP/CMD(h) agreed SPC wording for all antidepressants for Section 4.8, since suicidal ideation is not considered an adverse reaction in adult patients, but agreed to comply with the mandated class labelling.
Maltese: Il-MAH ma qabilx mal-formolazzjoni talkliem fl-SPC li sar qbil fuqha mal-PhVWP/CMD(h) għall-antidipressanti kollha għas-Sezzjoni 4.8, billi l-ideat suwiċidali mhumiex meqjusin bħala reazzjoni avversa fil-pazjenti adulti, iżda qabel li jikkonforma mal-ittikkettar tal-klassi ordnat.
English: Hypertension, Vasodilatation (mostly hot flashes/flushes), Palpitations
Maltese: Pressjoni għolja, Vażodilatazzjoni (laktar fwawar), Palpitazzjonijiet
English: The efficacy of venlafaxine immediate-release as a treatment for major depressive episodes was demonstrated in five randomised, double-blind, placebo-controlled, short-term trials ranging from 4 to 6 weeks duration, for doses up to 375 mg/day.
Maltese: L-effikaċja ta' venlafaxine li jerħi b'mod immedjat bħala kura għal episodji dipressivi maġġuri kienet murija f'ħames provi kliniċi randomised, double-blind u kkontrollati bil-plaċebo, li damu żmien qasir, minn 4 sa 6 ġimgħat, għal dożi sa 375 mg/kuljum.
English: At least 92% of venlafaxine is absorbed following single oral doses of immediate-release venlafaxine.
Maltese: Mill-inqas 92% ta' venlafaxine jiġi assorbit wara dożi orali waħidhom ta' venlafaxine li jerħi b'mod immedjat.
English: The SPC was amended according to the CHMP position.
Maltese: L-SPC kien emendat skont il-pożizzjoni tas-CHMP.
English: • Medicines containing linezolid, an antibiotic (used to treat infections)
Maltese: • Mediċini li fihom linezolid, antibijotiku (jintuża biex jikkura l-infezzjonijiet)
English: • Sight and hearing disorders Common: blurred vision
Maltese: • Disturbi fil-vista u fis-smigħ
English: With regards to cardiovascular safety, it was agreed that a contraindication was not warranted and that a revised wording for Section 4.4 was sufficient.
Maltese: Rigward is-sigurtà karjovaskulari, ġie miftiehem illi kontraindikazzjoni ma kinitx garantita u li kienet biżżejjed reviżjoni tal-kliem għasSezzjoni 4.4.
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 37.5 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Maltese: TAL-PRODOTT MEDIĊINALI Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta' 37.5 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: Steady-state concentrations of venlafaxine and ODV are attained within 3 days of oral multiple-dose therapy.
Maltese: Il-konċentrazzjonijiet fl-istat fiss ta' venlafaxine u ODV jintlaħqu fi żmien 3 ijiem ta' terapija b'doża orali multipla.
English: CNS-active substances
Maltese: Sustanzi attivi tas-CNS
English: Dry mouth is reported in 10% of patients treated with venlafaxine.
Maltese: Il-ħalq xott hu rrappurtat f'10% tal-pazjenti kkurati b'venlafaxine.
English: The clinical relevance of this finding in hypertensive patients is unknown.
Maltese: Ir-rilevanza klinika ta' din l-interazzjoni mhijiex magħrufa.
English: Haematological/ Lymphatic
Maltese: Sistema Ematoloġika / Limfatika
English: Abnormality of accommodation, Mydriasis, Visual disturbance,
Maltese: Anormalità ta' lakkomodazzjoni, Midrijasi, Disturb tal-vista
English: Akathisia/ Psychomotor restlessness, Convulsion, Manic reaction
Maltese: Akatisija / Nuqqas ta' kwiet psikomotor ju f'ġismek, Konvulżjon i,
English: The efficacy of venlafaxine prolonged-release as a treatment for major depressive episodes was established in two placebo-controlled, short-term studies for 8 and 12 weeks duration, which included a dose range of 75 to 225 mg/day.
Maltese: L-effikaċja ta' venlafaxine li jerħi bil-mod bħala kura għal episodji dipressivi maġġuri, kienet stabbilita f'żewġ studji kkontrollati bil-plaċebo, li damu 8 u 12-il ġimgħa, li kienu jinkludu medda ta' doża ta' 75 sa 225 mg/kuljum.
English: When stopping treatment with venlafaxine, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Maltese: Meta twaqqaf il-kura b'venlafaxine, id-doża għandha titnaqqas gradwalment fuq perjodu ta' mill-inqas ġimgħa sa ġimagħtejn, sabiex jitnaqqas ir-riskju ta' reazzjonijiet ta' meta tieqaf tieħu din il-mediċina (ara sezzjonijiet 4.4 u 4.8).
English: Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding Uncommon: abnormal orgasm (females)
Maltese: • Disturbi fis-sistema riproduttiva u sesswali Komuni: ejakulazzjoni/orgażmu anormali (irġiel); nuqqas ta' orgażmu; disfunzjoni erettili (impotenza); irregolaritajiet fil-mestrwazzjoni, bħal żieda fil-ħruġ tad-demm jew żieda fil-ħruġ irregolari tad-demm
English: It is unknown whether a pharmacokinetic and/or pharmacodynamic interaction with other benzodiazepines exists.
Maltese: Mhux magħruf jekk teżistix interazzjoni farmakokinetika u/jew farmakodinamika ma' benzodiazepines oħrajn.
English: Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI (see sections 4.3 and 4.4).
Maltese: Venlafaxine għandu jitwaqqaf għal mill-inqas 7 ijiem qabel ma tinbeda l-kura b'MAOI mhux selettiv irriversibbli (ara sezzjonijiet 4.3 u 4.4).
English: Furthermore, a statement was included in the harmonized SPC to highlight that controlled studies in children did not demonstrate efficacy of venlafaxine in the “major depressive disorder” indication.
Maltese: Barra minn hekk, ġiet inkluża stqarrija fl-SPC armonizzat biex tisħaq li l-istudji kkontrollati fit-tfal ma wrewx effikaċja ta' venlafaxine fl-indikazzjoni tad-“disturb dipressiv maġġuri”.
English: Venlafaxine was not mutagenic in a wide range of in vitro and in vivo tests.
Maltese: Venlafaxine ma kienx mutaġeniku f'firxa wiesgħa ta' testijiet in vitro u in vivo.
English: • Breathing disorders
Maltese: Sistema Respiratorja
English: The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment.
Maltese: Il-benefiċċju potenzjali għandu jintiżen kontra rriskju fil-kura ta' pazjenti b'indeboliment epatiku sever.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
Maltese: Informazzjoni mill-provi kliniċi wriet żieda fir-riskju ta' mġiba suwiċidali f'adulti żgħażagħ (ta' inqas minn 25 sena) b'kundizzjonijiet psikjatriċi li kienu kkurati b'anti-dipressant.
English: Appetite decreased (anorexia), Constipation, Vomiting
Maltese: Nuqqas t'aptit (anoreksja), Stitikezza, Rimettar
English: Reversible, selective MAO-A inhibitor (moclobemide) Due to the risk of serotonin syndrome, the combination of venlafaxine with a reversible and selective MAOI, such as moclobemide, is not recommended.
Maltese: Inibitur ta' MAO-A riversibbli u selettiv (moclobemide) Minħabba r-riskju tas-sindrome ta' serotonin, il-kumbinazzjoni ta' venlafaxine ma' MAOI riversibbli u selettiv, bħal moclobemide, mhijiex rakkomandata.
English: Havant, HANTS, P09 2NG,
Maltese: Havant, HANTS,
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Maltese: TAL-PRODOTT MEDIĊINALI Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta' 50 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 75 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Maltese: TAL-PRODOTT MEDIĊINALI Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta' 75 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: It is recommended that patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) be closely monitored.
Maltese: Hu rakkomandat li pazjenti bi pressjoni intraokulari għolja, jew pazjenti li qegħdin f'riskju għal glawkoma akuta ta' angolu dejjaq (glawkoma tat-tip angle-closure) ikunu mmonitorjati mill-qrib.
English: Convulsions may occur with venlafaxine therapy.
Maltese: Il-konvulżjonijiet jistgħu jseħħu bit-terapija ta' venlafaxine.
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Maltese: TAL-PRODOTT MEDIĊINALI Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta' 25 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari] Venlafaxine
English: Administration of activated charcoal may also limit absorption of the active substance.
Maltese: L-għoti ta' faħam attivat jista' wkoll jillimita l-assorbiment tas-sustanza attiva.
English: Age and gender Subject age and gender do not significantly affect the pharmacokinetics of venlafaxine and ODV.
Maltese: L-età u s-sess tal-pazjent ma jaffettwawx b'mod sinifikanti il-farmakokinetika ta' venlafaxine u ta' ODV.
English: Following the administration of venlafaxine prolonged-release capsules, peak plasma concentrations of venlafaxine and ODV are attained within 5.5 hours and 9 hours, respectively.
Maltese: Wara l-għoti ta' kapsuli ta' venlafaxine li jerħu l-mediċina bil-mod, il-konċentrazzjonijiet massimi fil-plażma ta' venlafaxine u ta' ODV jintlaħqu fi żmien 5.5 sigħat u 9 sigħat, rispettivament.
English: The volume of distribution for venlafaxine at steady-state is 4.4±1.6 L/kg following intravenous administration.
Maltese: Il-volum tad-distribuzzjoni għal venlafaxine fl-istat fiss hu ta' 4.4±1.6
English: Efexor is a treatment for adults with depression.
Maltese: Efexor hu kura għal adulti b'dipressjoni.
English: They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Maltese: Normalment iseħħu matul l-ewwel ftit jiem mit-twaqqif tal-kura, iżda kien hemm rapporti rari ħafna ta' sintomi bħal dawn f'pazjenti li qabżu doża bi żball.
English: Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
Maltese: Is-sinjali u s-sintomi tas-sindrome ta' serotonin jistgħu jinkludu kumbinazzjoni ta' dawn li ġejjin: nuqqas ta' kwiet f'ġismek, alluċinazzjonijiet, telf ta' koordinazzjoni, taħbit mgħaġġel tal-qalb, żieda fit-temperatura tal-ġisem, tibdil mgħaġġel fil-pressjoni tad-demm, riflessi sensittivi żżejjed, dijarea, koma, nawseja, rimettar.
English: Pharmacotherapeutic group: Other antidepressants - ATC code: NO6A X16.
Maltese: Anti-Dipressanti Oħrajn, Kodiċi ATC:
English: Because the total exposure (AUC) of venlafaxine and ODV is similar in poor and extensive metabolisers, there is no need for different venlafaxine dosing regimens for these two groups.
Maltese: Minħabba l-espożizzjoni totali (AUC) ta' venlafaxine u ODV hi simili f'metabolizzaturi batuti u estensivi, m'hemm l-ebda ħtieġa għal korsijiet differenti ta' dożaġġ ta' venlafaxine għal dawn iż-żewġ gruppi.
English: Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.
Maltese: Il-kura fl-istess ħin b'inibituri ta' monoamine oxidase irriversibbli (MAOIs) hi kontra-indikata minħabba r-riskju tas-sindrome ta' serotonin b'sintomi bħal aġitazzjoni, tregħid u ipertermija.
English: It is recommended that venlafaxine should be discontinued for at least 7 days before starting treatment with a reversible MAOI (see section 4.4).
Maltese: Hu rakkomandat li venlafaxine għandu jitwaqqaf għal mill-inqas 7 ijiem qabel ma tinbeda l-kura b'MAOI riversibbli (ara sezzjoni 4.4).
English: Syndrome (NMS), Serotonergic syndrome, Delirium, Extrapyramidal reactions (including dystonia and dyskinaesia), Tardive dyskinaesia, Suicidal ideation and behaviours**
Maltese: Reazzjonijiet Extrapiramidali (li jinkludu distonja u diskinesija), Diskinesija tardiva, Ħsieb biex jitwettaq suwiċidju u mġiba suwiċidali**
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħuda mill-Istati Membri dwar l-awtorizzazzjoni talprodott imsemmi hawn fuq (u l-ismijiet assoċjati), il-Kummissjoni Ewropea nnotifikat lis-Segretarjat tas-CHMP/EMEA b'riferiment uffiċjali skont l-Artikolu 30 tad-Direttiva 2001/83/KE kif emendat sabiex jiġu riżolti d-diverġenzi bejn l-SPCs awtorizzati fuq livell nazzjonali u b'hekk jiġu armonizzati l-SPCs diverġenti madwar l-UE.
English: Dizziness, sensory disturbances (including paraethesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, headache and flu syndrome are the most commonly reported reactions.
Maltese: Sturdament, disturbi sensorjali (li jinkludu parestesija), disturbi fl-irqad (li jinkludu nuqqas ta' rqad u ħolm intens), aġitazzjoni jew ansjetà, nawseja u/jew rimettar, tregħid, uġigħ ta' ras u s-sindrome ta' l-influwenza huma l-iktar reazzjonijiet li huma rrappurtati b'mod komuni.
English: Mean ± SD plasma steady-state clearances of venlafaxine and ODV are 1.3±0.6 L/h/kg and 0.4±0.2 L/h/kg, respectively.
Maltese: Għal pazjenti li jkunu jeħtieġu lemodijalisi u f'pazjenti b'indeboliment renali sever (GFR < 30 ml/min), id-doża għandha titnaqqas b'50%.
English: Angle-closure glaucoma
Maltese: Glawkoma tat-tip angle closure
English: As with other serotonergic agents, serotonin syndrome may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, or St. John's Wort [Hypericum perforatum]), with medicinal agents which impair metabolism of serotonin (including MAOIs), or with serotonin precursors (such as tryptophan supplements).
Maltese: Is-sindrome ta' serotonin, kundizzjoni li hi potenzjalment ta' periklu għall-ħajja, (ara “Effetti Sekondarji li Jista' Jkollu”), tista' sseħħ bil-kura ta' venlafaxine, partikularment meta jittieħed ma' mediċini oħrajn.
English: Metoprolol did not alter the pharmacokinetic profile of venlafaxine or its active metabolite, O-desmethylvenlafaxine.
Maltese: Metoprolol ma bidilx il-profil farmakokinetiku ta' venlafaxine jew talmetabolit attiv tiegħu, O-desmethylvenlafaxine.
English: The MAH was of the view that all MAOIs should be contraindicated with venlafaxine.
Maltese: M'hemm l-ebda antidoti speċifiċi disponibbli għal venlafaxine.
English: Examples of these medicines include:
Maltese: Kategorija farmakoterapewtika:
English: HOW TO TAKE EFEXOR
Maltese: X'fih Efexor
English: Efexor should be taken with food (see section 3 “HOW TO TAKE EFEXOR”).
Maltese: Efexor jista' jittieħed ma' l-ikel (ara Sezzjoni 3 “KIF GĦANDEK TIEĦU EFEXOR”).
English: Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia, Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Maltese: Ħruġ ta' demm mill-membrana mukuża, Titwil filħin ta' kemm idum ħiereġ id-demm, Tromboċitopenja, Diskrasiji taddemm, (li jinkludu agranuloċitosi, anemija aplastika, newtropenja u panċitopenja)
English: The MAH completed both the assessment of urinary disorders and of occurrence of gastrointestinal haemorrhage and agreed to add them to the adverse reaction table.
Maltese: Il-MAH lestiet kemm il-valutazzjoni tad-disturbi urinarji u tal-preżenza ta' emoraġija gastrointestinali u qabel li jżidhom mat-tabella tar-reazzjonijiet mhux mixtieqa.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġiba marbuta massuwiċidju (attentat ta' suwiċidju u ħsibijiet suwiċidali) u ostilità (il-biċċa l-kbira aggressjoni, imġiba li topponi, u rabja) kienu osservati b'mod aktar frekwenti fi provi kliniċi fost it-tfal u l-adolexxenti li kienu kkurati b'anti-dipressanti, meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: Mydriasis may occur in association with venlafaxine.
Maltese: Il-midrijasi tista' sseħħ b'rabta ma' venlafaxine.
English: Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day.
Maltese: Pazjenti li ma jkunux qed jirrispondu għad-doża tal-bidu ta' 75 mg/kuljum, jistgħu jibbenefikaw minn żidiet fid-doża sa doża massima ta' 375 mg/kuljum.
English: • Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
Maltese: John's Wort (imsejjaħ ukoll “Hypericum perforatum”, mediċina naturali jew li ġejja mill-ħxejjex li tintuża għall-kura ta' dipressjoni ħafifa)
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Maltese: Hi esperjenza klinika ġenerali li r-riskju ta' suwiċidju jista' jiżdied fl-istadji bikrin ta' l-irkuprar.
English: - “prevention of recurrence of major depressive episodes”, which was adequately supported by the data provided.
Maltese: - “il-prevenzjoni tar-rikorrenza ta' episodji dipressivi maġġuri”, li kienet appoġġjata b'mod adegwat mit-tagħrif ipprovdut.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of major depressive episodes.
Maltese: Għall-kura ta' episodji dipressivi maġġuri.
English: Samples from treated animals were collected at 4, 8, 12, 16, 20, 24 and 28 days after the end of treatment.
Maltese: Kampjuni minn annimali ttrattati nġabru f'4, 8, 12, 16, 20, 24 u 28 jum wara t-tmiem tat-trattament.
English: Belgium Ceva Sante Animale NV Metrologielaan 6
Maltese: Ceva Sante Animale NV Metrologielaan 6
English: Luxembourg Ceva Sante Animale NV Metrologielaan 6
Maltese: Il-Lussemburgu Ceva Sante Animale NV Metrologielaan 6
English: The veterinary medicinal products involved in this referral contain 250 mg/ml paromomycin sulfate as active substance (equivalent to 175 mg/ml paromomycin base or to a paromomycin activity of 175,000 IU/ml).
Maltese: Il-prodotti mediċinali veterinarji involuti f'din ir-referenza fihom 250 mg/ml paromomycin sulfate bħala sustanza attiva (ekwivalenti għal 175 mg/ml paromomycin bażi jew għal paromomycin attività ta' 175,000
English: Paromomycin belongs to the group of aminoglycoside antibiotics.
Maltese: Paromomycin jappartjeni għall-grupp ta' antibijotiċi bl-aminoglikosidi.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e. a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product ‘Parofor 175 mg/ml solution for injection', with Belgium as Reference Member State (BE/V/0027/003/DC).
Maltese: Ġiet ippreżentata applikazzjoni skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, jiġifieri, applikazzjoni ġenerika għal awtorizzazzjoni għat-tqegħid fis-suq skont il-proċedura deċentralizzata għall-prodott mediċinali veterinarju “Parofor 175 mg/ml soluzzjoni għall-injezzjoni”, bil-Belġju bħala l-Istat Membru ta' Referenza (BE/V/0027/003/DC).
English: Considering that colibacillosis is a disease complex (including neonatal diarrhoea, post-weaning diarrhoea, oedema disease, septicemia, polyserositis, coliform mastitis, and urinary tract infection) and is caused by different types of Escherichia coli (enteropathogenic E. coli, Shiga-toxin producing E. coli, enterotoxigenic E. coli, etc.), the marketing authorisation holders should define the clinical indication(s) as precisely as possible by including also the sub-category (age and production type) of the target animals.
Maltese: Meta wieħed iqis li l-kolibaċillożi hija kumpless ta' mard (inkluż dijarea neonatali, dijarea wara l-ftim, mard ta' edema, settiċemija, poliserosite, mastite koliformi u infezzjoni fl-apparat tal-awrina) u tiġi kkawżata minn tipi differenti ta' Escherichia coli (E. coli enteropatoġeniċi, E. coli li jipproduċu t-tossinu Shiga, E. coli enterotossiġeniċi, eċċ.), id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jiddefinixxu lindikazzjoni(jiet) klinika(ċi) b'mod preċiż kemm jista' jkun billi jinkludu wkoll is-sottokategorija (età u tip ta' produzzjoni) tal-annimali fil-mira.
English: • Treatment of E. coli involved in swine colibacillosis (neonatal diarrhoea, post-weaning diarrhoea, oedema disease) and against Actinobacillus pleuropneumoniae strains with a
Maltese: • Trattament ta' E. coli involuti fil-kolibaċillożi tal-ħnieżer (dijarea neonatali, dijarea wara l ftim, marda ta' edema) u kontra razez ta' Actinobacillus pleuropneumoniae b'MIC ≤ 4 mg/l.
English: o Potential effect(s) on the user safety;
Maltese: o Valutazzjoni tal-impatt ambjentali o Effett(i) potenzjali fuq is-sigurtà tal-utent;
English: 2600 Antwerpen Belgium
Maltese: 1130 Brussel Belgium
English: The quantification of paromomycin in tissues was carried out by validated HPLC-MS/MS analytical methods.
Maltese: Il-kwantifikazzjoni ta' paromomycin fit-tessuti saret permezz ta' metodi analitiċi HPLC-MS/MS ivvalidati.
English: The withdrawal period was determined in animals with a mean weight of 37.2 kg (range of 32 to 42.8 kg) treated according to the recommended posology at the longest duration of treatment.
Maltese: Il-perjodu ta' tiżmim ġie determinat f'annimali b'piż medju ta' 37.2 kg (medda ta' 32 sa 42.8 kg) ittrattati skont il-pożoloġija rakkomandata għall-itwal durata tat-trattament.
English: The reference product is ‘Gabbrovet solution injectable', which has been authorised in a few Member States.
Maltese: Il-prodott ta' referenza huwa “Gabbrovet soluzzjoni injettabbli”, li ġie awtorizzat fi ftit Stati Membri.
English: Parofor 175 mg/ml
Maltese: Parofor 175 mg/ml Paromomycin 175 mg/ml
English: It may be administered by parenteral route.
Maltese: Dan jista' jingħata b'mod parenterali.
English: A pharmacokinetic study was carried out in target animals at the recommended dose (14 mg/kg bodyweight of paromomycin).
Maltese: Sar studju farmakokinetiku f'annimali fil-mira bid-doża rakkomandata (14 mg/kg piż tal-ġisem ta' paromomycin).
English: Regarding A. pleuropneumoniae, the PK/PD analysis based on the inhibitory quotient (Cmax/MIC >8 to 10) shows that only 10% of the target bacterial population would be sensitive to paromomycin administered at the recommended posology.
Maltese: Fir-rigward ta' A. pleuropneumoniae, l-analiżi PK/PD ibbażata fuq il-kwozjent inibitorju (Cmax/MIC >8 sa 10) turi li 10 % biss tal-popolazzjoni batterika fil-mira tkun sensittiva għal paromomycin li jingħata filpożoloġija rakkomandata.
English: o Potential effects on target animal tolerance.
Maltese: o Effetti potenzjali fuq it-tolleranza tal-annimal fil-mira.