FrancophonIA/ELRC3.0 huggingface dataset:
English: The application was submitted to France as reference Member State and to Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom as concerned Member States.
Maltese: L-applikazzjoni ġiet ippreżentata lil Franza bħala Stat Membru ta' referenza u lill-Awstrija, il-Belġju, id-Danimarka, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Lussemburgu, ilPortugall, is-Slovenja, Spanja u r-Renju Unit bħala Stati Membri kkonċernati.
English: Pfizer Hellas AE Mesogion Avenue 243 154 51 N. Psychiko Athens
Maltese: Pfizer Hellas AE Mesogion Avenue 243 154 51 N.
English: 6-8 weeks immatures
Maltese: Forom immaturi ta' 6-8 ġimgħat
English: Parasite
Maltese: Parassita
English: Via Isonzo 71 04100 Latina Italy
Maltese: Pfizer Italia S.r.l. Via Isonzo 71 04100 Latina L-Italja
English: Gastro-intestinal nematodes: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Respiratory tract nematode: Dictyocaulus viviparus TREMATODES
Maltese: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Nematodi respiratorji:
English: Ramsgate Road Sandwich CT13 9NJ United Kingdom
Maltese: Ir-Renju Unit Pfizer Ltd Ramsgate Road Sandwich CT13 9NJ Ir-Renju Unit
English: The results showed efficacy above 95% except on day 7 (94.5%) and day 28 (87.5%).
Maltese: Ir-riżultati wrew effikaċja li taqbeż il-95% ħlief fis-seba' jum (94.5%) u t-28 jum (87.5%).
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, saħħa tal-prodotti mediċinali veterinarji, speċi ta' annimal, metodu ta' amministrazzjoni, detentur tal-awtorizzazzjoni għal-tqegħid fis-suq fl-iStati Membri
English: The comparable efficacy of the moxidectin/triclabendazole pour-on combination product (Cydectin TriclaMox) compared to moxidectin alone in the same vehicle was studied in a pharmacokinetics trial.
Maltese: L-effikaċja komparabbli tal-prodott ta' kombinazzjoni li jitferra' ta' moxidectin/triclabendazole (Cydectin TriclaMox) meta mqabbel ma' moxidectin waħdu fl-istess vettura kien studjat fi prova farmakokinetika.
English: A confirmatory trial was provided where the efficacy of moxidectin/triclabendazole pour-on combination in cattle was studied at the recommended dose rate of Cydectin TriclaMox (0.5 mg moxidectin/20 mg triclabendazole/kg body weight) against natural infestations of sucking and/or biting lice, with emphasis primarily on Linognatus vituli and secondarily on Bovicola bovis by comparison with a placebo-treated control group.
Maltese: Ingħatat prova konfermatorja fejn l-effikaċja tal-kombinazzjoni li titferra' ta' moxidecton/triclabendazole fil-frat ġiet studjata bir-rata ta' doża rakkomandatata ta' Cydectin TriclaMox (0.5 mg moxidectin/20 mg triclabendazole għal kull kg ta' piż tal-ġisem) kontra infestazzjonijiet naturali ta' qamel li jerda' u/jew li jigdem, b'enfasi primarja fuq Linognatus vituli u sekondarjament fuq Bovicola bovis meta mqabbel ma' grupp ta' kontroll ikkurat bil-plaċebo.
English: • the CVMP reviewed all available data submitted by the marketing authorisation holder, to support the indication for treatment of lice infestations caused by Linognatus vituli, Bovicola bovis and Solenopotes capillatus;
Maltese: • is-CVMP, abbażi tad-dejta disponibbli kkunsidra li tista' tkun mistennija effikaċja sodisfaċenti għal Linognatus vituli, Bovicola bovis u Solenopotes capillatus;
English: Pfizer Animal Health submitted an application for a type II variation to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) and reference was made to the monoproduct, Cydectin pour-on containing moxidectin alone and for which the claim against lice was already granted.
Maltese: Pfizer Animal Health ippreżentat applikazzjoni għal varjazzjoni tat-Tip II biex iżżid indikazzjoni ġdida kontra l-ispeċijiet ta' qamel (Linognatus vituli, Bovicola bovis u Solenopotes capillatus) u saret referenza għall-monoprodott li jitferra' Cydectin, li fih moxidectin waħdu u li għalih t-talba kontra lqamel kienet diġà ngħatat.
English: Inhibited stages
Maltese: Stadju inibit
English: Belgium Pfizer Animal Health s.a. Rue Laid Burniat 1
Maltese: Pfizer Animal Health s.a. Rue Laid Burniat 1 1348 Louvain-la-Neuve Il-Belġju
English: The CVMP based the extrapolation of the efficacy of the product on Linognatus vituli to the two other lice species proposed (Bovicola bovis and Solenopotes capillatus) on the results of a dose determination study with the monoproduct containing moxidectin as active substance where the three proposed claimed lice species were shown to be controlled (>95 % except for Solenopotes capillatus adult before day 21) at half dose for the monoproduct (0.25 mg/kg bw instead of 0.5 mg/kg bw), supported by the pharmacokinetics finding giving no strong signal of interaction between the two active substances in Cydectin TriclaMox.
Maltese: Is-CVMP ibbaża l-estrapolazzjoni tal-effikaċja tal-prodott fuq Linognatus vituli għaż-żewġ speċijiet ta' qamel l-oħra proposti (Bovicola bovis u Solenopotes capillatus) fuq ir-riżultati ta' studju ta' determinazzjoni tad-doża bil-monoprodott li fih moxidectin bħala sustanza attiva fejn ħareġ li t-tliet speċijiet ta' qamel proposti msemmija ġew ikkontrollati (>95 % ħlief għall-adult Solenopotes capillatus qabel il-21 jum) b'nofs doża għall-monoprodott (0.25 mg/kg bw minflok 0.5 mg/kg bw), appoġġjata mis-sejba tal-farmakokinetika li ma tat l-ebda sinjal ta' interazzjoni b'saħħitha bejn iż-żewġ sustanzi attivi f'Cydectin TriclaMox.
English: Based on (i) the comparable pharmacokinetic profiles for moxidectin when administered as the combination product compared with moxidectin alone in the same vehicle, (ii) the findings of the confirmatory study with Linognatus vituli and (iii) the data from the original moxidectin 0.5% pour-on dossier showing that Linognatus vituli, Bovicola bovis and Solenopotes capillatus were sensitive to moxidectin at half the recommended dose rate (0.25 mg/kg), the CVMP considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field for Cydectin TriclaMox.
Maltese: Abbażi ta' (i), il-profili farmakokinetiċi komparabbli għal moxidectin meta jingħata bħala l-prodott ta' kombinazzjoni meta mqabbel ma' moxidectin waħdu fl-istess vettura, (ii) is-sejbiet tal-istudju konfermatorju b'Linognatus vituli u (iii) id-dejta mid-dossier dwar is-sustanza li titferra' ta' 0.5% ta' moxidectin oriġinali li turi li Linognatus vituli, Bovicola bovis u Solenopotes capillatus kienu sensittivi għal moxidectin b'nofs ir-rata ta' doża rakkomandata (0.25 mg/kg), is-CVMP ikkunsidra li wieħed jista' jistenna effikaċja sodisfaċenti għal Linognatus vituli, Bovicola bovis u Solenopotes capillatus fil-qasam għal Cydectin TriclaMox.
English: Avda.
Maltese: Anness
English: Pfizer GmbH Linkstraße 10 10785 Berlin Germany
Maltese: Il-Ġermanja Pfizer GmbH Linkstraße 10
English: Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains of:
Maltese: Trattament ta' infezzjonijiet imħallta ta' trematodi (fluke) u nematodi u ċerti infestazzjonijiet ta' artropodi ikkawżati minn razez ta' dawn sensittivi għal moxidectin u triclabendazole:
English: In absence of a strong signal, these data can be considered supportive data of the clinical data analysed below.
Maltese: Fin-nuqqas ta' sinjal b'saħħtu, din id-dejta tista' titqies bħala dejta ta' appoġġ għad-dejta klinika analizzata hawn taħt.
English: Germany
Maltese: Berlin
English: Cydectin TriclaMox pour-on solution is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Maltese: Is-soluzzjoni li titferra' ta' Cydectin TriclaMox hija prodott mediċinali veterinarju li fiha 5 mg ta' moxidection għal kull ml u 200 mg ta' triclabendanzole għal kull ml.
English: Greece
Maltese: Il-Finlandja
English: Package leaflet:
Maltese: Fil-baqar:
English: This issue remained unsolved and therefore a CMD(v) procedure under Article 13 of Commission Regulation (EC) No 1234/2008 started on 14 January 2013.
Maltese: Din il-kwistjoni baqgħet ma ġietx solvuta u għalhekk fl-14 ta' Jannar 2013 ingħata bidu għal proċedura CMD(v) skont l-Artikolu 13 tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008.
English: In order to address the concerns raised by Belgium the MAH provided data to support the noninterference between triclabendazole and moxidectin, a clinical study regarding the efficacy against Linognatus vituli and Bovicola bovis and literature on the efficacy of moxidectin against lice species.
Maltese: Sabiex jiġi indirizzat it-tħassib imqajjem mill-Belġju, l-MAH ipprovda dejta biex jappoġġja n-nuqqas ta' interferenza bejn triclabendazole u moxidectin, studju kliniku dwar l-effikaċja kontra Linognatus vituli u Bovicola bovis u dokumentazzjoni dwar l-effikaċja ta' moxidectin kontra l-ispeċijiet ta' qamel.
English: While acknowledging the absence of commingling of the animals which is a worst-case-scenario according to the CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)1, as a limitation in the study, the CVMP considered the study well conducted.
Maltese: Filwaqt li ġie rikonuxxut li n-nuqqas ta' taħlit tal-annimali li skont il-linji gwida tas-CVMP dwar irrekwiżiti speċifiċi ta' effikaċja għall-ektoparassitiċidi fil-frat huwa l-agħar xenarju (EMEA/CVMP/625/03)1, bħala limitu fl-istudju, is-CVMP ikkunsidra li l-istudju twettaq sew.
English: (Invented) name Strength
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Adjuvant MF59C.1 containing squalene (9.75 milligrams), polysorbate 80 (1.175 milligrams), sorbitan trioleate (1.175 milligrams)
Maltese: Adjuvant MF59C.1 li fih squalene (9.75 milligrammi), polysorbate 80 (1.175 milligrammi), sorbitan trioleate (1.175 milligrammi)
English: Packagin
Maltese: Isem Qawwa
English: 7.5 micrograms** per 0.5 ml dose
Maltese: 5.0 ml (1 doża = 0.5 ml)
English: 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/7/2009 (H1N1)v like strain used (X-179A)
Maltese: A/California/7/2009 (H1N1)v tixbah razza (X-179A) 7.5 mikrogrami** kull 0.5 ml doża * propogat fil-bajd ** mfisser f'mikrogrammi ta' emaglutinin
English: Strength Pharmaceutica l Form
Maltese: Għamla farmaċewtika
English: Content (concentration)
Maltese: Kunjett (ħġieġ)
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Maltese: 1 Antigeni tal-wiċċ tal-virus tal-influwenza (emaglutinin u neuraminidase)* tar-razza:
English: 10 pre-filled syringes vial (glass) 5.0 ml
Maltese: 10 siringi mimlijin għallest
English: Invented name
Maltese: Kontenut
English: Content Package size Withdrawal period
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: San Sebastian de los Reyes, Spain
Maltese: San Sebastian de los Reyes, Spanja
English: {Name and address} {tel} {fax} {e-mail}
Maltese: {Isem u Indirizz} {tel} {fax} {e-mail}
English: 2130 AG HOOFDDORP The Netherlands
Maltese: 2130 AG HOOFDDORP L-Olanda
English: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens Greece
Maltese: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens Il-Greċja
English: Germany Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster
Maltese: Il-Ġermanja Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster
English: Denmark Wyeth AB Dalvägen 12
Maltese: Id-Danimarka Wyeth AB Dalvägen 12
English: 12, B.O.BOX 1822, 17124 Solna Sweden
Maltese: 12, B.O.BOX 1822, 17124 Solna
English: Luxembourg Wyeth Pharmaceuticals SA/NV Rue du Bosquet,15
Maltese: Lussemburgu Wyeth Pharmaceuticals SA/NV Rue du Bosquet,15
English: Neuroleptic Malignant Syndrome (NMS), Serotonergic syndrome, Delirium,
Maltese: Sindrome Malinn Newroleptiku (NMS), Sindrome Serotonerġiku, Delirju,
English: Erythema multiforme, Toxic epidermal necrolysis, StevensJohnson syndrome, Pruritus, Urticaria
Maltese: Eritema multiforme, Nekrolisi epidermali tossika, Sindrome ta' StevensJohnson, Ħakk, Urtikarja
English: Czech Republic, Romania
Maltese: Ir-Repubblika Ceka, ir-Rumanija
English: Efexor depot has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Efexor ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi talProdott (SPC), miġbura mis-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendat.
English: Belgium Wyeth Pharmaceuticals SA/NV Rue du Bosquet,15
Maltese: Wyeth Pharmaceuticals SA/NV Rue du Bosquet,15
English: *[Please note that not all listed products and strengths may be available.]
Maltese: *[Jekk jogħġbok innota li mhux il-prodotti u l-qawwiet kollha jistgħu jkunu disponibbli.]
English: • Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Efexor depot”).
Maltese: • Inibituri ta' monoamine oxidase (MAOIs: ara s-sezzjoni “Qabel ma tieħu Efexor depot”)
English: Wyeth AB Box 1822, 171 24 Solna Sweden
Maltese: Wyeth AB Box 1822, 171 24 Solna L-Iżvezja
English: SE - 17124 Solna Sweden
Maltese: SE - 17124 Solna L-Iżvezja
English: Wyeth AB, Dalvägen
Maltese: Il-Finlandja Wyeth AB, Dalvägen
English: • Psychiatric problems, such as hyperactivity and euphoria
Maltese: • Problemi psikjatriċi, bħal iperattività u ewforja.
English: Box 1822
Maltese: P.O. Box 1822
English: The Netherlands Wyeth Pharmaceuticals B.V. P.O.
Maltese: Wyeth Pharmaceuticals B.V. P.O. Box 255
English: Frequency cannot be estimated from the available data
Maltese: Mhux magħrufa Frekwenza ma tistax tkun stmata mid-dejta disponibbli
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10%), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), mhux magħrufa (ma tistax tittieħed stima middejta disponibbli)
English: 171 42 Solna, Sweden
Maltese: 171 42 Solna, L-Iżvezja
English: Abnormal liver function tests, Hyponatraemia, Hepatitis, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Prolactin increased
Maltese: Testijiet talfunzjoni tal-fwied b'riżultat anormali, Iponatremija, Epatite, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Żieda fil-Prolactin
English: Cyprus, Greece, Estonia, Lithuania, Portugal Efexor XR
Maltese: Ċipru, il-Greċja, l-Estonja, il-Litwanja, ilPortugall
English: Akathisia/ Psychomotor restlessness, Convulsion, Manic reaction
Maltese: Akatisija / Nuqqas ta' kwiet psikomotorj u f'ġismek, Konvulżjoni, Reazzjoni Manika
English: Venlafaxine is extensively metabolised, primarily to the active metabolite, O-desmethylvenlafaxine (ODV).
Maltese: Venlafaxine hu metabolizzat b'mod estensiv, primarjament għall-metabolit attiv Odesmethylvenlafaxine (ODV).
English: The efficacy of venlafaxine prolonged-release capsules as a treatment for generalised anxiety disorder (GAD) was established in two 8-week, placebo-controlled, fixed-dose studies (75 to 225 mg/day), one 6-month, placebo-controlled, fixed-dose study (75 to 225 mg/day), and one 6-month, placebo-controlled, flexible-dose study (37.5, 75, and 150 mg/day) in adult outpatients.
Maltese: L-effikaċja tal-kapsuli ta' venlafaxine li jerħu l-mediċina bil-mod bħala kura għal disturb ta' ansjetà ġeneralizzata (Generalized Anxiety Disorder - GAD) kienet stabbilita f'żewġ studji li damu 8 ġimgħat li kienu kkontrollati bil-plaċebo, li fihom ingħatat doża fissa (75 sa 225 mg/kuljum), studju li dam 6 xhur, ikkontrollat bil-plaċebo, li fih ingħatat doża fissa (75 sa 225 mg/kuljum), u studju li dam 6 xhur, ikkontrollat bil-plaċebo, li fih ingħatat doża flessibbli (37.5, 75 u 150 mg/kuljum) f'pazjenti adulti outpatients.
English: Efexor depot is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs).
Maltese: Efexor depot hu anti-dipressant li jappartjeni għal grupp ta' mediċini msejħa inibituri ta' lassorbiment mill-ġdid ta' serotonin u norepinephrine (SNRIs).
English: Efectin ER 37,5 mg trde kapsules podaljšanim sproščanjem Efectin ER 75 mg trde kapsule s podaljšanim sproščanjem
Maltese: Efectin ER 37,5 mg trde kapsule s podaljšanim sproščanjem Efectin ER 75 mg trde kapsule s podaljšanim sproščanjem
English: Denmark, Finland, Iceland, Norway, Sweden Efexor Depot France
Maltese: Id-Danimarka, il-Finlandja, l-Islanda, inNorveġja, l-Iżvezja
English: Abnormal dreams, Decreased libido, Dizziness, Increased muscle tonus (hypertonia), Insomnia, Nervousness, Paresthesia, Sedation, Tremor, Confusion, Depersonalisation
Maltese: Ħolm anormali, Nuqqas ta' libido, Sturdament, Żieda fit-tonus talmuskoli (ipertonija), Nuqqas ta' rqad, Nervożità, Parestesija, Sedazzjoni, Tregħid, Konfużjoni, Dipersonalizzazzjoni
English: Trevilor retard 37,5 mg Trevilor retard 75 mg Trevilor retard 150 mg
Maltese: Trevilor retard 37,5 mg Trevilor retard 75 mg Trevilor retard 150 mg l-Irlanda, Malta, Ir-Renju Unit
English: Serotonin syndrome may occur with the concomitant use of venlafaxine and lithium (see Serotonin syndrome).
Maltese: Is-sindrome ta' serotonin jista' jseħħ bl-użu fl-istess ħin ta' venlafaxine u lithium (ara Is-sindrome ta' serotonin).
English: The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.
Maltese: Iddoża massima għal disturb ta' ansjetà ġeneralizzata, disturb ta' ansjetà soċjali u disturb ta' paniku hi ta' 225 mg/kuljum.
English: The MAH was asked to harmonise Section 4.3, for which the following differences between SPCs needed to be evaluated: - Monoamine oxidase inhibitors (MAOIs); - Cardiovascular safety - Uncontrolled hypertension.
Maltese: Il-MAH intalab jarmonizza s-Sezzjoni 4.3, li għal liema kellhom jiġu evalwati d-differenzi bejn lSPCs - Inibituri tal-Monoamine oxidase (MAOIs); - Sigurtà kardjovaskulari; - Pressjoni għolja mhux ikkontrollata.
English: SPC Section 4.2 - Posology and Method of Administration The MAH was asked to harmonise the following posology texts in the SPC: - limitations of treatment duration of the maximum daily dose of 375mg to 4 weeks; - differences in maximum recommended daily dose.
Maltese: Sezzjoni 4.2 tal-SPC - Pożoloġija u metodu ta' kif għandu jingħata Il-MAH intalab jarmonizza t-testi li ġejjin dwar il-pożoloġija fl-SPC: - limitazzjonijiet tat-tul tat-trattament tad-doża massima ta' kuljum ta' 375mg għal 4 ġimgħat; - differenzi fid-doża massima rakkomandata ta' kuljum.
English: The efficacy of venlafaxine prolonged-release capsules as a treatment for social anxiety disorder was established in four double-blind, parallel-group, 12-week, multi-center, placebo-controlled, flexible-dose studies and one double-blind, parallel-group, 6-month, placebo-controlled, fixed/flexible-dose study in adult outpatients.
Maltese: L-effikaċja tal-kapsuli ta' venlafaxine li jerħu l-mediċina bil-mod bħala kura għad-disturb ta' ansjetà soċjali kienet stabbilita f'erba' studji li damu 12-il ġimgħa, double-blind, parallel-group, multiċentriċi, ikkontrollati bil-plaċebo, li fihom ingħatat doża flessibbli, u studju li dam 6 xhur, doubleblind, parallel-group, ikkontrollat bil-plaċebo, li fih ingħatat doża fissa/flessibbli f'pazjenti adulti outpatients.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Maltese: Meta-analiżi ta' provi kliniċi kkontrollati bil-plaċebo ta' mediċini kontra d-dipressjoni f'pazjenti adulti b'disturbi psikjatriċi, uriet żieda fir-riskju ta' mġiba suwiċidali bl-anti-dipressanti meta mqabbla mal-plaċebo f'pazjenti ta' inqas minn 25 sena.
English: In clinical trials, adverse events seen on treatment discontinuation (tapering and post-tapering) occurred in approximately 31% of patients treated with venlafaxine and 17% of patients taking placebo.
Maltese: Fil-provi kliniċi, l-avvenimenti avversi li kienu osservati meta twaqqfet il-kura (mat-twaqqif gradwali u wara t-twaqqif gradwali) seħħew f'madwar 31% talpazjenti kkurati b'venlafaxine u fi 17% tal-pazjenti li kienu qed jieħdu l-plaċebo.
English: Abnormal ejaculation/orgas m (males), Anorgasmia, Erectile dysfunction (impotence), Urination impaired (mostly hesitancy), Menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g., menorrhagia, metrorrhagia), Pollakiuria
Maltese: Ejakulazzjoni/orgażmu anormali (irġiel), Anorgażmija, Disfunzjoni erettili (impotenza), Indeboliment meta tagħmel l-awrina (laktar dewmien biex tibda tagħmel l-awrina), Disturbi talmestrwazzjoni assoċjati ma' żieda fil-ħruġ taddemm jew żieda filħruġ ta' demm irregolari (eż., mestrwazzjoni esaġerata, tnixxija anormali tad-demm mill-ġuf), pollakijurja
English: FURTHER INFORMATION What Efexor depot contains The active substance is venlafaxine.
Maltese: Is-sustanza attiva hi venlafaxine.
English: Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia , Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Maltese: Tromboċitopenja, Diskrasiji taddemm, (li jinkludu agranuloċitosi, anemija aplastika, newtropenja u panċitopenja)
English: Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/day Efexor depot is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonized SPC.
Maltese: Episodji Dipressivi Maġġuri: is-CHMP qies li d-doża massima ta' 375mg kuljum ta' Efexor hija sigura u effikaċi minn perspettiva fit-tul u rrakkomanda li din tkun approvata mingħajr limitazzjonjiet fir-rigward tat-tul ta' żmien fl-SPC armonizzat.
English: Withdrawal symptoms seen on discontinuation of venlafaxine: based on a proposed text for the SPC for for Selective Serotonin Reuptake Inhibitors (SSRIs) / Selective Norepinephrine Reuptake Inhibitors (SNRIs) (Sections 4.2, 4.4, and 4.8) reviewed by the Pharmacovigilance Working Party, it was agreed to incorporate this text into the harmonised SPC.
Maltese: Sintomi ta' rtirar li dehru mat-twaqqif ta' venlafaxine: skont test propost għall-SPC għall-Inibituri Selettivi tal-Assorbiment mill-Ġdid tas-Serotonin (SSRIs) u l-Inibituri Selettivi tal-Assorbiment millĠdid tan-Norepinephrine (SNRIs) (Sezzjonijiet 4.2, 4.4, u 4.8) analizzati mill-Grupp ta' Ħidma talFarmakoviġilanza, kien hemm qbil li jiġi inkorporat dan it-test fl-SPC armonizzata.
English: Efectin ER 150 mg - Kapseln 150 mg Modified-release capsule, hard
Maltese: Efectin ER 150 mg - Kapseln 150 mg Kapsula li terħi il-mediċina b'mod modifikat, iebsa
English: Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Maltese: Xi pazjenti jista' jkollhom sintomi bħal għeja, sturdament, mejt, uġigħ ta' ras, nuqqas ta' rqad, ħmar il-lejl, ħalq xott, telf ta' aptit, nawseja, dijarea, nervożità, aġitazzjoni, konfużjoni, tisfir fil-widnejn, tnemnim jew, rarament, sensazzjonijiet ta' xokk elettriku, dgħjufija, għaraq, aċċessjonijiet jew sintomi bħal ta' l-influwenza..
English: Belgium, Luxembourg
Maltese: Il-Belġju, il-Lussemburgu