FrancophonIA/ELRC3.0 huggingface dataset:
English: Owner-reported measure of their dog's anxiety symptoms (based on Lincoln Sound Sensitivity Scale) during a noise event: The sum scores showed a statistically significant treatment effect favouring imepitoin with a difference in anxiety score between imepitoin and placebo of -6.1; p < 0.0001, 95% CI [-8.6;-3.6].
Maltese: Il-punteġġi magħduda urew effett tal-kura statistikament sinifikanti favur imepitoin b'differenza fil-punteġġ tal-ansjetà bejn imepitoin u l-plaċebo ta' -6.1; p < 0.0001, 95% CI
English: Metabolite profiles in urine and faeces revealed four major inactive metabolites which are formed by oxidative modification.
Maltese: Il-profili tal-metaboliti fl-awrina u fl ippurgar żvelaw erba' metaboliti maġġuri inattivi li jiffurmaw permezz ta' modifikazzjoni ossidattiva.
English: No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section 4.8).
Maltese: Ma tista' tinstilet l-ebda konklużjoni definittiva dwar l-effikaċja ta' imepitoin bħala terapija miżjuda għal phenobarbital, potassium bromide u/jew levetiracetam mill-istudji limitati disponibbli (ara ssezzjoni 4.8).
English: Pharmacokinetic studies indicate that imepitoin is well absorbed (> 92%) after oral administration and that no pronounced first pass effect occurs.
Maltese: Studji farmakokinetiċi jindikaw li imepitoin jiġi assorbit tajjeb (> 92%) wara l-għoti mill-ħalq u li ma jseħħ l-ebda effett first pass notevoli.
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia, emesis, polyphagia at the beginning of treatment, somnolence (very common); hyperactivity, apathy, polydipsia, diarrhoea, disorientation, anorexia, hypersalivation, polyuria (common); prolapsed nictitating membrane and decreased sight (isolated reports).
Maltese: Ir-reazzjonijiet avversi ħfief u ġeneralment temporanji li ġejjin ġew osservati fi studji qabel l-użu kliniku u studji kliniċi għad-dikjarazzjoni tal-epilessija kklassifikati skont frekwenza dejjem tonqos: atassija, emesi polifaġija ġiet irrappurtata fil-bidu tal-kura, ngħas (komuni ħafna); iperattività, apatija, polidipsija, dijarea, diżorjentament, anoressija, ipersalivazzjoni, poliurja (komuni); prolapsed nictitating membrane u tnaqqis żgħir fil-vista (rapporti iżolati).
English: No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section “Interactions”).
Maltese: Ma tista' tinstilet l-ebda konklużjoni definittiva dwar l-effikaċja ta' imepitoin bħala terapija miżjuda għal phenobarbital, potassium bromide u/jew levetiracetam mill-istudji limitati disponibbli (ara ssezzjoni Interazzjoni).
English: Overdose (symptoms, emergency procedures, antidotes) In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kilogram bodyweight, neurological effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted.
Maltese: F'każ ta' doża eċċessiva ripetuta b'5 darbiet l-ogħla doża rakkomandata ta' 30 mg imepitoin għal kull kilogramma piż tal-ġisem, ġew osservati effetti newroloġiċi, effetti b'konnessjoni gastrointestinali u titwil riversibbli tal-intervall tal-QT.
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia (loss of coordination), emesis (vomiting), polyphagia (increased appetite) at the beginning of treatment, somnolence (drowsiness) (very common); hyperactivity (much more active than usual), apathy, polydipsia (increased thirst), diarrhoea, disorientation, anorexia (loss of appetite), hypersalivation (increased saliva production), polyuria (increased urine production) (common); prolapsed nictitating membrane (visible third eyelid) and decreased sight (isolated reports).
Maltese: Ir-reazzjonijiet avversi ħfief u ġeneralment temporanji li ġejjin ġew osservati fi studji qabel l-użu kliniku u studji kliniċi għad-dikjarazzjoni ta' epilessija kklassifikati skont frekwenza dejjem tonqos: atassja (telf ta' koordinazzjoni), emesi (remettar), polifaġija (żieda fl-aptit) ġiet irrappurtata fil-bidu tal-kura, sonnolenza (ngħas) (komuni ħafna), iperattività (il-kelb ikun ħafna iktar attiv mis-soltu), apatija, polidipsija (żieda fl-għatx), dijarea, diżorjentament, anoressija (telf ta' aptit), ipersalivazzjoni
English: Elimination
Maltese: MANIFATTURA
English: At such doses, the symptoms are not usually lifethreatening and generally resolve within 24 hours if symptomatic treatment is given.
Maltese: F'dawn id-dożi, is-sintomi normalment ma jkunux ta' periklu għall-ħajja u ġeneralment jgħibu fi żmien 24 siegħa jekk tingħata kura sintomatika.
English: The safety of the veterinary medicinal product has not been tested in dogs weighing less than 2 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġietx ittestjata fi klieb li jiżnu inqas minn 2 kg jew fi klieb bi problemi tas-sigurtà bħal mard tal-kliewi, tal-fwied, tal-qalb, gastrointestinali jew mard ieħor.
English: Oral administration at a dose range of 10 mg to 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart.
Maltese: Għoti mill-ħalq f'doża ta' bejn 10 mg u 30 mg ta' imepitoin għal kull 1kg ta' piż tal-ġisem darbtejn kuljum, f'intervall ta' 12-il siegħa.
English: The difference between imepitoin and phenobarbital groups in the seizure frequency per month after treatment (adjusted for baseline difference) was 0.004, 95% CI [-0.928, 0.935].
Maltese: Id-differenza bejn il-gruppi ta' imepitoin u phenobarbital fil-frekwenza ta' puplesiji kull xahar wara l-kura (aġġustata għad-differenza fil-linja bażi) kienet ta' 0.004, 95 % CI
English: Assuming that the veterinary medicinal product is well tolerated by the dog, the dose can be increased by 50 to 100% increments up to a maximum dosage of 30 mg per kg administered twice daily.
Maltese: Jekk wieħed jassumi li l-prodott mediċinali veterinarju jiġi ttollerat tajjeb, id-doża tista' tiżdied b'inkrementi ta' 50 sa 100% sa dożaġġ massimu ta' 30 mg kull kg mogħtija darbtejn kuljum.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat)
English: A mild elevation in plasma creatinine, urea and cholesterol levels has been observed in dogs treated with imepitoin; however these generally did not exceed the normal reference ranges and were not associated with any clinically significant observations or events.
Maltese: Żieda ħafifa fil-livelli tal-kreatinina, urea u tal-kolesterol fil-plażma ġiet osservata fi klieb ikkurati b'imepitoin; madankollu, ġeneralment dawn ma qabżux il-meded ta' referenza normali u ma kinux assoċjati ma' kwalunkwe osservazzjonijiet jew avvenimenti klinikament sinifikanti.
English: See also section "Pregnancy and lactation".
Maltese: Ara wkoll is-sezzjoni "Tqala u treddigħ".
English: No loss of anticonvulsant efficacy (tolerance development) during continuous treatment of 4 weeks was observed in experimental studies lasting 4 weeks.
Maltese: Ma ġie osservat l-ebda telf ta' effikaċja kontra l-konvulżjonijiet (żvilupp ta' tolleranza) matul kura kontinwa ta' 4 ġimgħat fi studji sperimentali li damu 4 ġimgħat.
English: 400 mg tablet
Maltese: Pillola ta' 400 mg
English: 100 mg tablet
Maltese: Pillola ta' 100 mg
English: Pexion 400 mg tablets for dogs imepitoin
Maltese: Pexion 100 mg pilloli għall-klieb Pexion 400 mg pilloli għall-klieb imepitoin
English: Clinical trial in noise phobia In a placebo-controlled field trial with a treatment duration of 3 days, the efficacy of imepitoin was investigated in dogs diagnosed with noise phobia during the traditional New Year's Eve fireworks.
Maltese: Fi prova klinika prattika kkontrollata bi plaċebo b'durata ta' 3 ijiem tal-kura, l-effikaċja ta' imepitoin ġiet investigata fi klieb djanjostikati b'fobija għall-istorbju matul il-logħob tan-nar tradizzjonali ta' lejlet l-Ewwel tas-Sena.
English: For the efficacy analysis, 226 dogs (104 imepitoin, 122 placebo) were eligible (at least one dose of medication & data for evaluation of co-primary endpoints), and the following results were observed for the two co-primary endpoints: Owner assessed overall effect of study treatment (based on signs during a noise event and a comparison to signs during a previous noise event(s) without treatment: The cumulative odds of a good or excellent effect were significantly greater in the imepitoin group compared with the placebo group (Odds Ratio = 4.689; p < 0.0001, 95% CI [2.79;7.89]).
Maltese: Fi prova Ewropea fil-kamp (field trial) li qabblet l-effikaċja ta' imepitoin ma' phenobarbital f'226 kelb b'epilessija idjopatika ddijanjostikata għall-ewwel darba, 45% tal-każijiet mill-grupp ta' imepitoin u 20% mill-grupp ta' phenobarbital kienu esklużi mill-analiżi tal-effikaċja għal raġunijiet li kienu jinkludu li naqsu li jirrispondu għall-kura.
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia, increased appetite, lethargy (very common); emesis, aggression (see section 4.5) (common); hyperactivity, somnolence, hypersalivation (uncommon).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew osservati matul l-istudji prekliniċi u kliniċi mwettqa b'appoġġ għad-dikjarazzjoni ta' fobija għall-istorbju: atassja, żieda fl-aptit, letarġija (komuni ħafna); emesi, aggressjoni (ara sezzjoni 4.5) (komuni); iperattività, ngħas, ipersalivazzjoni (mhux komuni).
English: Pharmacotherapeutic group: Antiepileptics, Other antiepileptics, imepitoin ATCvet code: QN03AX90
Maltese: Epilessija idjopatika Minħabba n-natura tal-epilessija, ir-rispons farmakoloġiku għall-kura jista' jvarja.
English: Imepitoin is extensively metabolised prior to elimination.
Maltese: Imepitoin jiġi metabolizzat b'mod estensiv qabel it-tneħħija.
English: In the remaining dogs (64 dogs for Pexion and 88 dogs for phenobarbital), the following clinical results were observed: Mean frequency of generalised seizures was reduced from 2.3 seizures per month in the imepitoin group and from 2.4 seizures per month in the phenobarbital group to 1.1 seizures per month in both groups after 20 weeks of treatment.
Maltese: Medja tal-frekwenza ta' puplesiji ġeneralizzati tnaqqset minn 2.3 puplesiji kull xahar fil-grupp ta' imepitoin u minn 2.4 puplesiji kull xahar fil-grupp ta' phenobarbital għal 1.1 puplesiji kull xahar fiż-żewġ gruppi wara 20 ġimgħa ta'
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia (loss of coordination), increased appetite, lethargy (very common); emesis (vomiting), aggression (see section “Special warnings”) (common); hyperactivity, somnolence (drowsiness), hypersalivation (uncommon).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew osservati matul l-istudji prekliniċi u kliniċi mwettqa b'appoġġ tad dikjarazzjoni tal-fobija għall-istorbju: atassja (telf tal-koordinazzjoni), żieda fl-aptit, letarġija (komuni ħafna); emesi (remettar), aggressjoni (ara sezzjoni “Twissijiet speċjali”) (komuni); iperattività,
English: For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
Maltese: Għat-tnaqqis tal-frekwenza ta' puplesiji ġeneralizzati minħabba epilessija idjopatika fil-klieb għall-użu wara evalwazzjoni bir-reqqa ta' għażliet ta' kura alternattiva.
English: PACKAGE SIZE 30 tablets 100 tablets 250 tablets
Maltese: DAQS TAL-PAKKETT 30 pillola
English: The anxiolytic effect of imepitoin is mediated via the GABAA receptor.
Maltese: Dawn is-sinjali huma potenzjalment relatati mal-kura.
English: Absorption
Maltese: KWANTITÀ
English: Consideration should be given to use of a behavioural modification programme.
Maltese: Għandu jiġi kkunsidrat l-użu ta' programm ta' modifika tal-imġiba.
English: The product has been used in combination with phenobarbital, potassium bromide and/or in a small number of cases with levetiracetam and no harmful clinical interactions were observed (see section 4.4).
Maltese: .8 Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni Il-prodott intuża flimkien ma' phenobarbital, potassium bromide u/jew levetiracetam f'numru żgħir ta' każijiet ma' levetiracetam u l-ebda interazzjonijiet kliniċi ta' ħsara ma ġew osservati (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/147/002 250 tablets (100 mg)
Maltese: EU/2/12/147/002 250 pillola (100 mg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 30, 100 and 250 tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kartuna għal 30, 100 jew 250 pillola
English: Number of tablets (to be given twice daily) for noise phobia treatment: Dose: 30 mg/kg twice daily
Maltese: Doża: 30 mg/kg darbtejn kuljum Numru ta' pilloli għal kull amministrazzjoni Piż tal-ġisem (kg)
English: Ingestion of this product may cause dizziness, lethargy and nausea.
Maltese: L-inġestjoni ta' dan il-prodott tista' tikkawża sturdament, letarġija u dardir.
English: Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders.
Maltese: Tużax fi klieb b'indeboliment sever fil-funzjoni tal-fwied, disturbi severi tal-kliewi jew disturbi kardjovaskulari severi.
English: Imepitoin also inhibits seizures via potentiation of the GABAA receptor-mediated inhibitory effects on the neurons and in addition, imepitoin has a weak calcium channel blocking effect which may contribute to its anticonvulsive properties.
Maltese: Jekk il-puplesiji ma jiġux ikkontrollati b'mod adegwat, miżuri dijanjostiċi addizzjonali u kura oħra kontra l epilessija għandhom jiġu kkunsidrati.
English: Deslorelin
Maltese: Deslorelina
English: This summary was last updated in March 2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Marzu 2012.
English: Other information about Suprelorin:
Maltese: Informazzjoni oħra dwar Suprelorin:
English: Suprelorin has been studied under field conditions in dogs weighing between 10 and 25 kg which were implanted before being followed up for up to a year and in ferrets weighing between 1 and 1.7 kg which were implanted at the beginning of the breeding season before being followed up for up to 6 months.
Maltese: Superlorin ġie studjat taħt kondizzjonijiet bażi fuq klieb li jiżnu bejn 10 u 25 kg li ġew impjantati qabel ma ġew segwiti għal sena u fuq inmsa li jiżnu bejn kilogramm u 1.7 kg li ġew impjantati filbidu tal-istaġun tat-tnissil qabel ma ġew segwiti għal 6 xhur.
English: This suppresses (blocks) the production of follicle stimulating hormone (FSH) and luteinising hormone (LH).
Maltese: Dan irażżan (jimblokka) l-produzzjoni tal-ormon li jistimula l-folliklu (follicle stimulating hormone (FSH)) u l-ormon tal-lutenizzazzjoni (LH).
English: Suprelorin is an implant containing the active substance deslorelin.
Maltese: Suprelorin huwa impjant li fih is-sustanza attiva deslorelina.
English: The active substance in Suprelorin, deslorelin, acts like the natural hormone gonadotropinreleasing hormone (GnRH) which controls the secretion of other hormones involved in fertility.
Maltese: Is-sustanza attiva f'Suprelorin, id-deslorelina, taġixxi bħall-ormon naturali, l-ormon li jirrilaxxa lgonadotropina (gonadotropin-releasing hormone (GnRH)) li jikkontrolla s-sekrezzjoni ta' ormoni oħrajn involuti fil-fertilità.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tasCVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: All studies showed a reduction of testosterone levels in the blood, a reduction in the size of the testicles, decreased libido and decreased spermatogenesis (when fewer sperm are produced by the testicles).
Maltese: L-istudji kollha wrew tnaqqis fil-livelli ta' testosteron fid-demm, tnaqqis fid-daqs tat-testikoli, tnaqqis fil-ġibda sesswali u spermatoġeneżi mnaqqsa (meta t-testikoli jipproduċu inqas sperma).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suprelorin on 10/07/2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Suprelorin fl-10/07/2007.
English: What is Suprelorin?
Maltese: X'inhu Suprelorin?
English: Why has Suprelorin been approved?
Maltese: Għaliex ġie approvat Suprelorin?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suprelorin outweigh its risks for the induction of temporary infertility in healthy, entire, sexually mature male dogs and ferrets and recommended that Suprelorin be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Suprelorin huma akbar mir-riskji tiegħu għall-induzzjoni ta' infertilità temporanja fi klieb u inmsa irġiel b'saħħithom, sesswalment maturi u rrakkomanda li Suprelorin jingħata awtorizzazzjoni għattqegħid fis-suq.
English: The effect continues for six months in the case of the 4.7 mg implant for dogs and 12 months in the case of the 9.4 mg implant for dogs (16 months for ferrets) after which the dog and ferret can be re-implanted if necessary.
Maltese: L-effett jibqa' għal sitt xhur fil-każ tal-impjant 4.7 mg għall-klieb u 12-il xahar fil-każ tal-impjant 9.4 mg għall-klieb (16-il xahar għall-inmsa) u wara dan il-kelb u n-nemes jistgħu jiġi impjantati mill-ġdid jekk ikun meħtieġ.
English: In more than 95% of dogs, these effects started at six weeks after implantation and between 5 and 14 weeks in treated ferrets after implantation.
Maltese: F'aktar minn 95% tal-klieb, dawn l-effetti bdew sitt ġimgħat wara l-impjantazzjoni u bejn 5 ġimgħat u 14-il ġimgħa f'inmsa kkurati wara l-impjantazzjoni.
English: Any swelling or local reaction resolves naturally.
Maltese: Kull nefħa jew reazzjoni lokali tgħaddi b'mod naturali.
English: The return to normal fertility after the end of the treatment has not been investigated in ferrets.
Maltese: Fl-inmsa, r-ritorn għal fertilità normali wara t-tmiem tal-kura ma ġiex investigat.
English: What is the risk associated with Suprelorin?
Maltese: X'inhu r-riskju assoċjat ma' Suprelorin?
English: The implant is inserted subcutaneously, under the loose skin on the back between the lower neck and the lumbar area in dogs and between the shoulder blades in ferrets.
Maltese: Din il-mediċina veterinarja ġiet żviluppata apposta għall-klieb u l-inmsa u m'għandhiex tintuża fuq il-bnedmin.
English: Suprelorin is given as an implant that slowly releases a continuous low dose of deslorelin.
Maltese: Suprelorin jingħata bħala impjant li bil-mod il-mod jirrilaxxa doża baxxa kontinwa tad-deslorelina.
English: Suprelorin starts being effective after about six weeks in dogs and between 5 to 14 weeks in ferrets.
Maltese: Suprelorin jibda jkun effettiv wara madwar sitt ġimgħat fil-klieb u bejn 5 ġimgħat sa 14-il ġimgħa fl-inmsa.
English: As a result in male dogs and ferrets less testosterone circulates in the blood, the dog and ferret stop producing sperm and its libido is reduced.
Maltese: B'konsegwenza ta' dan, fi klieb u inmsa irġiel jiċċirkola inqas testosteron fid-demm, il-kelb u n-nemes jieqfu jipproduċi sperma u l-ġibdiet sesswali tagħhom jonqsu.
English: Ferrets can have transient moderate swelling, itching and redness at the implant site.
Maltese: L-inmsa jista' jkollhom nefħa moderata temporanja, ħakk u ħmura fis-sit tal-impjantazzjoni.
English: The safety of Suprelorin was studied after giving dogs more than 10 times and ferrets more than 6 times the recommended dose rate.
Maltese: Is-sigurtà ta' Suprelorin ġiet studjata wara li l-klieb ingħataw aktar minn 10 darbiet u l-inmsa aktar minn 6 darbiet ir-rata tad-doża rakkomandata.
English: How has Suprelorin been studied?
Maltese: Kif ġie studjat Suprelorin?
English: 1 Brunton, L. L.; Chabner, Bruce; Knollmann, Björn C. 2011.
Maltese: 1 Brunton, L. L.; Chabner, Bruce;
English: In the EU the originator product for amitriptyline is marketed as Saroten (and associated names including Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex and Redomex Diffucaps).
Maltese: Fl-UE, il-prodott oriġinatur għal amitriptyline jitqiegħed fis-suq bħala Saroten (u ismijiet assoċjati inkluż Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex u Redomex Diffucaps).
English: Based on the drug reference Martindale (Martindale 2014) the recommended dose for nocturnal enuresis is 10 mg to 20 mg for children aged 6 to 10 years and 25 mg to 50 mg for children aged 11 years to 17 years.
Maltese: Abbażi tar-referenza tal-mediċina Martindale, (Martindale 2014) id-doża rakkomandata għal nocturnal enuresis hija ta' 10 mg sa 20 mg għat-tfal li għandhom bejn 6 u 10 snin u ta' 25 mg sa 50 mg għal tfal li għandhom bejn 11 u 17-il sena.
English: - Recent myocardial infarction.
Maltese: - Infart mijokardjali riċenti.
English: Saroten is available for oral use in film-coated tablets and modified-release capsules and tablets, with strengths including 10, 25, 50 and 75 mg.
Maltese: Saroten jiġi għal użu orali f'pilloli miksijin b'rita u f'kapsuli ta' rilaxx modifikat u pilloli, b'qawwiet inkluż 10, 25, 50 u 75 mg.
English: Section 4.5 of the SmPC on drug interactions was revised based on a review of the latest literature available.
Maltese: Is-sezzjoni 4.5 tal-SmPC dwar interazzjonijiet mediċinali ġiet riveduta abbażi ta' rieżami tal-aħħar letteratura disponibbli.
English: As part of the assessment of a previous PSUR procedure for amitriptyline (PSUSA/0000168/201501), the Lead Member, Greece, identified the need to harmonise the product information for the originator Saroten across the EU.
Maltese: Bħala parti mill-valutazzjoni ta' proċedura preċedenti tal-PSUR għal amitriptyline (PSUSA/0000168/201501), il-Membru Prinċipali, il-Greċja, identifika l-bżonn li tiġi armonizzata linformazzjoni dwar il-prodott għall-oriġinatur Saroten fl-UE kollha.
English: - Concomitant treatment with MAOIs (monoamine oxidase inhibitors) - Severe liver disease.
Maltese: - Kura fl-istess ħin b'MAOIs (inibituri ta' monoamine oxidase) - Mard gravi fil-fwied.
English: The therapeutic effect is normally seen after 2-4 weeks of dosing.
Maltese: L-effett terapewtiku normalment jidher wara 2-4 ġimgħat ta' dożaġġ.
English: Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency.
Maltese: Kwalunkwe grad ta' mblokkar tal-qalb jew disturbi tar-ritmu kardijaku u insuffiċjenza tal-arterja koronarja.
English: The MAHs proposed harmonised dosing recommendations based on the doses studied in clinical trials and in line with the reference book Martindale (Martindale 2014).
Maltese: L-MAHs ipproponew rakkomandazzjonijiet ta' dożaġġ armonizzati abbażi tad-dożi studjati fi provi kliniċi u skont il-ktieb ta' referenza Martindale (Martindale 2014).
English: Amitriptyline was first approved by the US in 1961.
Maltese: Amitriptyline l-ewwel ġie approvat mill-Istati Uniti fl-1961.
English: It is also available as solution for injection (2ml, 50 mg).
Maltese: Dan jiġi wkoll bħala soluzzjoni għall-injezzjoni (2ml, 50 mg).