qanastek/EMEA-V3 huggingface dataset:
Looking at the results of studies where triple combination treatment was used (such as a study called VALIANT), the CHMP noted that as there was no increased mortality in patients receiving all three medicines, and therefore there should be no concerns regarding the triple combination.
Meta ħares lejn ir- riżultati ta ’ studji fejn intużat kura b’ kombinazzjoni tripla (bħal fil- każ ta ’ studju msejjaħ VALIANT), is- CHMP innota li ma kien hemm ebda żieda fil- mortalità tal- pazjenti li kienu qed jirċievu t- tliet mediċini f’ daqqa, u għaldaqstant m’ għandux ikun hemm tħassib rigward il - kombinazzjoni tripla.
However the Committee agreed that such a combination should still not be recommended until there is more evidence to support its positive benefit-risk balance.
Madankollu l- Kumitat qabel li kombinazzjoni bħal din xorta m’ għandiex tkun irrakkomandata sakemm ma jkunx hemm aktar provi li jsostnu l- bilanċ pożittiv bejn il- benefiċċji u r - riskji tiegħu.
In conclusion, the CHMP endorsed the following text: “ The recommended starting dose of Diovan is 40 mg twice daily.
Għalhekk, is- CHMP approva t- test li ġej: “ Id- doża tal- bidu rakkomandata ta ’ Diovan hija ta ’ 40 mg darbtejn kuljum.
Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Iż- żieda fid- doża għal 80 mg u 160 mg darbtejn kuljum għandha ssir f’ distanza ta ’ mill- anqas ġimgħatejn sal- ogħla doża, kif ittollerat mill- pazjent.
Consideration should be given to reducing the dose of concomitant diuretics.
Għandu jiġi kkunsidrat it- tnaqqis tad- doża ta ’ dijuretiċi konkomitanti.
The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Id- doża massima ta ’ kuljum mogħtija fil- provi kliniċi hija ta ’ 320 mg f’ dożi maqsuma.
Valsartan may be administered with other heart failure therapies.
Valsartan jista ’ jingħata ma ’ terapiji oħra tal- insuffiċjenza tal- qalb.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Madankollu, il- kombinazzjoni tripla ta ’ inibitur ACE, imblokkatur beta u valsartan mhix rakkomandata (ara taqsimiet 4. 4 u 5. 1).
Evaluation of patients with heart failure should always include assessment of renal function .”
L- evalwazzjoni ta ’ pazjenti b’ insuffiċjenza tal- qalb għandha dejjem tinkludi eżami tal- funzjoni renali. ”
Contraindications The CHMP noted that there was a divergence on whether the use of Diovan should be contraindicated in patients with kidney failure.
Kontraindikazzjonijiet Is- CHMP innota li kien hemm nuqqas ta ’ qbil dwar jekk l- użu ta ’ Diovan għandux ikun kontraindikat f’ pazjenti b’ insuffiċjenza tal- kliewi.
Having assessed the data available, the CHMP agreed that valsartan 80 mg can be used as a starting dose in patients with reduced kidney function.
Wara li evalwa d- dejta disponibbli, is- CHMP qabel li valsartan ta ’ 80 mg jista ’ jintuża bħala doża tal- bidu f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi.
The Committee noted that there has been no study of valsartan in patients with severe kidney failure, but they did not identify any possible safety issue has he primary route of elimination of valsartan is via the digestive (biliary), not renal route The CHMP therefore recommended that the contraindication be removed.
Is- CHMP għalhekk irrakkomanda li l - kontraindikazzjoni għandha titneħħa.
However, because Diovan is eliminated via the biliary route, the CHMP agreed that it should be contraindicated in patients with severe liver diseases and “ should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction”.
Madankollu, minħabba li Diovan jitneħħa permezz tar- rotta biljari, is- CHMP qabel li għandu jkun kontraindikat f’ pazjenti b’ mard serju tal- fwied u “ m’ għandux jingħata lil pazjenti bi problemi epatiċi serji, ċirrożi jew ostruzzjoni biljari ”.
The CHMP also aligned the contraindication for the use of Diovan during pregnancy or lactation with recent the recommendations of the Pharmacovigilance experts, and therefore recommended that the contraindication in pregnancy be removed and the recommendation for the use during breast feeding be: “ Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles
Is- CHMP ġab il- kontraindikazzjoni għall- użu ta ’ Diovan waqt it- tqala jew it- treddiegħ f’ linja mar - rakkomandazzjonijiet reċenti tal- esperti tal- Farmakoviġilanza, u għaldaqstant irrakkomanda li l - kontraindikazzjoni fit- tqala titneħħa u li r- rakkomandazzjoni għall- użu matul it- treddiegħ għandha
2 during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
2 tkun: “ Minħabba li m’ hemm l- ebda informazzjoni disponibbli rigward l- użu ta ’ valsartan matul it - treddiegħ, Diovan (Valsartan) mhux rakkomandat u huwa aħjar l- użu ta ’ kuri alternattivi bi profili ta ’ sigurtà stabbiliti aħjar waqt it- treddiegħ, b’ mod speċjali waqt it- treddiegħ ta ’ tarbija tat- twelid jew tarbija li twieldet qabel iż- żmien ”.
Special precautions The CHMP considered the need to harmonise a number of precautions for use: • concomitant use of other medicinal products containing, or raising the level of, potassium.
Prekawzjonijiet speċjali Is- CHMP ikkunsidra l- ħtieġa li jarmonizza għadd ta ’ prekawzjonijiet għall- użu: • użu konkomitanti ta ’ prodotti oħra mediċinali li fihom, jew li jgħollu l- livell ta ’, potassju.
The CHMP endorsed the following text: “ If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”. • patients with liver impairment or cholestasis (problems with the elimination of bile). The Committee agreed that no initial dose adjustment is needed in patients with mild to moderate impairment of liver function.
Il- Kumitat qabel li mhux meħtieġ l- aġġustament tad- doża tal- bidu f’ pazjenti b’ insuffiċjenzi żgħar jew moderati tal - funzjoni tal- fwied.
However, the dose of valsartan should not exceed 80 mg in patients with cholestasis and should be used with caution.
Madankollu, id- doża ta ’ valsartan m’ għandhiex taqbeż it- 80 mg f’ pazjenti b’ kolestażi u għandu jintuża b’ kawtela.
The CHMP endorsed following text:
Is- CHMP approva t- test li ġej:
No dosage adjustment is required for patients with a creatinine clearance > 10ml/ min.
Mhux meħtieġ l- aġġustament tad- doża għal pazjenti bi clearance tal- kreatinina > 10ml/ min.
In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Id- doża ta ’ valsartan m’ għandhiex taqbeż it- 80 mg f’ pazjenti bi problemi epatiċi żgħar jew moderati mingħajr kolestażi (ara taqsima 4. 4).
The CHMP also updated other parts of the products information to put it in line with the new data available.
Is- CHMP aġġorna wkoll partijiet oħra tal- informazzjoni dwar il- prodott biex din tinġieb f’ linja mad - dejta ġdida disponibbli.
The amended information to doctors and patients is available here.
L- informazzjoni emendata għat- tobba u l- pazjenti hija disponibbli hawnhekk.
For publication with complete documentation after commission decision:
Għall- pubblikazzjoni mad- dokumentazzjoni sħiħa wara deċiżjoni tal- Kummissjoni:
The European Commission issued a decision on 16 February 2009.
Il- Kummissjoni Ewropea ħarġet deċiżjoni fis- 16 ta ’ Frar 2009.
Company responses provided on:
Data tal- bidu tar- riferiment:
Dr Alar Irs (Estonia) Dr Liv Mathison (Norway) 24 April 2008 20 October 2008 20 November 2008
Dr Alar Irs (Estonja) Dr Liv Mathison (Norveġja) 24 ta ’ April 2008
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA ’ ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, ID- DETENTURI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
1 Member State Marketing Authorisation Holder
1 Stat Membru
(Invented)
Isem (ivvintat)
Route of administration
L- Awstrija
Austria Wyeth-Lederle Pharma GmbH Storchengasse 1 1150 Vienna Austria
Wyeth- Lederle Pharma GmbH Storchengasse 1 1150 Vienna L- Awstrija
Modified-release capsule, hard
Kapsula li terħi il- mediċina b' mod modifikat, iebsa
Wyeth Pharmaceuticals SA/ NV Rue du Bosquet,15 1348 Louvain-la-Neuve Belgium
Wyeth Pharmaceuticals SA/ NV Rue du Bosquet, 15 1348 Louvain- la- Neuve Il- Belġju
Prolonged-release capsules
Kapsuli li jerħu l- mediċina bil- mod
Wyeth-Lederle Pharma GmbH Storchengasse 1 A-1150 Vienna Austria
Wyeth- Lederle Pharma GmbH Storchengasse 1 A- 1150 Vienna L- Awstrija
Prolonged-release capsule, hard
Kapsula iebsa li terħi l- mediċina bil - mod
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens Greece
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athens Il- Greċja
Czech Republic
Ir- Repubblika Ceka
Wyeth-Lederle Pharma GmbH., Storchengasse 1 1150 Vienna Austria
Wyeth- Lederle Pharma GmbH., Storchengasse 1 1150 Vienna L- Awstrija
3 Denmark
3 Id- Danimarka
Prolonged-release capsule, hard
Kapsula iebsa li terħi l- mediċina bil -
Box 1822 SE - 17124 Solna Sweden
Box 1822 SE - 17124 Solna L- Iżvezja
Wyeth Lederle Pharma GmbH Storchengasse 1 A-1150 Vienna Austria
Wyeth Lederle Pharma GmbH Storchengasse 1 A- 1150 Vienna L- Awstrija
Prolonged-release capsules, hard
Kapsuli iebsin li jerħu l- mediċina bil - mod
Wyeth AB, Dalvägen 12, B. O. BOX 1822, 17124 Solna Sweden
Wyeth AB, Dalvägen 12, B. O. BOX 1822, 17124 Solna L- Iżvezja
4 Finland
4 Il- Finlandja
Wyeth Pharmaceuticals France Coeur Défense - Tour A - La Défense 4 92931 Paris La Défense Cedex, France
Wyeth Pharmaceuticals France Coeur Défense - Tour A - La Défense 4 92931 Paris La Défense Cedex, Franza
Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Germany
Wyeth Pharma GmbH Wienburgstrasse 207, D- 48159 Muenster Il- Ġermanja
5 Germany
5 Il- Ġermanja
Prolonged-release capsule
Kapsula li terħi l- mediċina bil- mod
Wyeth AB Box 1822, 171 24 Solna Sweden
Wyeth AB Box 1822, 171 24 Solna L- Iżvezja
6 Ireland
6 L- Irlanda
John Wyeth & Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
John Wyeth & Brother Ltd. li tagħmel il- kummerċ bħala Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Ir- Renju Unit
Prolonged release-Capsules
Kapsuli li jerħu l- mediċina bil- mod
Kildare Ireland
Kildare L- Irlanda
Prolonged-release hard capsules
Kapsuli iebsin li jerħu l- mediċina bil - mod
Italy
7 L- Italja
7 Latvia
Il- Latvja
Luxembourg
Lussemburgu
Prolonged release-Capsules
Kapsuli li jerħu l- mediċina bil- mod n
Box 255 2130 AG HOOFDDORP The Netherlands
Box 255 2130 AG HOOFDDORP L- Olanda
Prolonged release capsules
Kapsuli li jerħu l- mediċina bil- mod
9 Poland
Il- Polonja
António Loureiro Borges, 2 Arquiparque – Miraflores 1495-131 Algés Portugal
António Loureiro Borges, 2 Arquiparque – Miraflores 1495- 131 Algés Il- Portugall
Romania
10 Ir- Rumanija
10 Romania
Ir- Rumanija
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes, Spain
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes, Spanja
General Mitre, 151 08022 Barcelona Spain
General Mitre, 151 08022 Barcelona Spanja
Wyeth AB Box 1822 171 42 Solna, Sweden
Wyeth AB Box 1822 171 42 Solna, L- Iżvezja
John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Ir- Renju Unit
Modified Release Capsule
Kapsula li terħi il- mediċina b' mod modifikat
12 United Kingdom
12 Ir- Renju Unit
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, IT- TIKKETTA U L- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EFEXOR DEPOT AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU GLOBALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ EFEXOR DEPOT U L - ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
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.
Efexor ġie inkluż fil- lista ta ’ prodotti għall- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal - Prodott (SPC), miġbura mis- CMD( h), skont l- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE, kif emendat.
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.
Minħabba d- deċiżjonijiet nazzjonali diverġenti meħuda mill- Istati Membri dwar l- awtorizzazzjoni tal - prodott 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.
The following Sections of the Product Information were addressed during this harmonisation procedure.
Is- Sezzjonijiet li ġejjin tal- Fuljett ta ’ Tagħrif ġew indirizzati waqt din il- proċedura tal - armonizzazzjoni.
SPC Section 4.1 - Therapeutic Indications Following the European Commission’ s request, Section 4.1 of the Summary of Product Characteristics was harmonized to include the following therapeutic indications as worded and described below:
Sezzjoni 4. 1 tal- SPC – Indikazzjonijiet Terapewtiċi Wara talba mill- Kummissjoni Ewropea, is- Sezzjoni 4. 1 tas- Sommarju tal- Karatteristiċi tal- Prodott ġiet armonizzata biex tinkludi l- indikazzjonijiet terapewtiċi li ġejjin kif ifformulati u deskritti hawn taħt:
- “ treatment of major depressive episodes”, with no inclusion of references to associated anxiety,
- “ it- trattament ta ’ episodji dipressivi maġġuri ”, mingħajr ebda inklużjoni ta ’ referenza għall- ansjetà
given that the studies designed to investigate the anxiolytic effect of venlafaxine revealed that it is difficult to distinguish anxiety from the concomitant depression disorder;
assoċjata magħhom, fid- dawl tal- fatt li l- istudji mfasslin biex jinvestigaw l- effett ta ’ kontra l- ansjetà ta ’ venlafaxine wrew li huwa diffiċli li wieħed jiddistingwixxi l- ansjetà mid- disturbi dipressiva konkomittanti;
- “ prevention of recurrence of major depressive episodes”, which was adequately supported by the
- “ il- prevenzjoni tar- rikorrenza ta ’ episodji dipressivi maġġuri ”, li kienet appoġġjata b’ mod adegwat
data provided.
mit- tagħrif ipprovdut.
(The “ prevention of relapse of depression” indication was excluded since, based on current EU guidelines, the relapse indication is encompassed when approval for the indication of major depressive episodes is granted).
(L- indikazzjoni “ prevenzjoni tat- tqanqil mill- ġdid tad- dipressjoni ” ġiet eskluża billi, skont il- linji gwida attwali tal- UE, l- indikazzjoni tat- tqanqil mill- ġdid hija inkorporata meta tingħata l- approvazzjoni għall- indikazzjoni tal- episodji dipressivi maġġuri).
A minority of CHMP members were of the opinion that this indication should be deleted from section 4.1, and a statement should be included in section 4.2, to indicate that longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes.
Minoranza ta ’ membri tas- CHMP kienu tal- fehma li din l- indikazzjoni m’ għandhiex titħassar mis- sezzjoni 4. 1, u għandha tkun inkluża stqarrija fis- sezzjoni 4. 2, biex tindika li t- trattament fit- tul jista ’ jkun xieraq ukoll għall - prevenzjoni tar- rikorrenza ta ’ episodji dipressivi maġġuri.
SPC Section 4.2 - Posology and Method of Administration The MAH was asked to harmonise the following posology texts in the SPC:
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:
- limitations of treatment duration of the maximum daily dose of 375mg to 4 weeks;
- limitazzjonijiet tat- tul tat- trattament tad- doża massima ta ’ kuljum ta ’ 375mg għal 4 ġimgħat;
- differences in maximum recommended daily dose.
- differenzi fid- doża massima rakkomandata ta ’ kuljum.
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.
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.
Additionally, it was agreed to clarify in the SPC that dose increments should only be made after a clinical evaluation, and that the lowest effective dose should be maintained, given the risk of dose-related adverse effects.
Użu fil- pazjenti anzjani: fid- dawl tat- tagħrif ippubblikat li żied il- possibilità ta ’ indeboliment tal - kliewi u l- potenzjal għal tibdiliet fis- sensitività tan- newrotrażmettitur u l- affinità maż- żieda fl- età, kien hemm qbil dwar formolazzjoni ġdida tal- kliem fl- SPC.
No safety problems were associated with doses higher than 75mg/ day, which may also be beneficial for some patients.
Kien hemm qbil li “ L- ebda aġġustament fid- doża ma huwa meħtieġ abbażi tal- età waħedha tal- pazjent ”.
Additionally, it was clarified in the SPC that dose increments should only be made after a clinical evaluation and that the lowest effective dose should be maintained, given the risk of dose-related adverse effects.
Madankollu, fl- SPC armonizzat ġiet inkluża wkoll rakkomandazzjoni biex tiġi eżerċitata kawtela fit- trattament ta ’ pazjenti anzjani, biex tintuża l- iżgħar doża effettiva u biex issir sorveljanza bir- reqqa ta ’ pazjenti anzjani meta tkun meħtieġa żieda fid- doża.
Panic Disorder:. the MAH was asked to discuss the risk/ benefit for the panic indication in more detail, comparing the safety and efficacy for the 75 mg dose with the suggested 225 mg dose.
Użu fit- tfal u l- adolexxenti taħt it- 18- il sena: kien hemm qbil li “ Venlafaxine mhuwiex rakkomandat għall- użu fit- tfal u fl- adolexxenti ”.
The CHMP concurred with the MAH that patients may benefit from individualising the dose within the effective range of 75 to 225 mg.
Barra minn hekk, ġiet inkluża stqarrija fl- SPC armonizzat biex
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.
15 tisħaq li l- istudji kkontrollati fit- tfal ma wrewx effikaċja ta ’ venlafaxine fl- indikazzjoni tad - “ disturb dipressiv maġġuri ”.
Use in patients with hepatic impairment: it was agreed to recommend in the SPC the individualization of dosage to overcome clearance variability between patients with hepatic impairment.
Użu fil- pazjenti b’ indeboliment tal- fwied: kien hemm qbil li l- SPC jirrakkomanda l - individwalizzazzjoni tad- doża biex tingħeleb il- varjabilità fit- tneħħija bejn pazjenti b’ indeboliment tal- fwied.
Use in patients with renal impairment: it was agreed that the individualisation of the dosage may be desirable, and this concept was introduced in the text for harmonization.
Użu fil- pazjenti b’ indeboliment tal- kliewi: kien hemm qbil li l- individwalizzazzjoni tad- doża tista ’ tkun mixtieqa, u dan il- kunċett ġie introdott fit- test għall- armonizzazzjoni.
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.
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 mill - Ġdid tan- Norepinephrine (SNRIs) (Sezzjonijiet 4. 2, 4. 4, u 4. 8) analizzati mill- Grupp ta ’ Ħidma tal - Farmakoviġilanza, kien hemm qbil li jiġi inkorporat dan it- test fl- SPC armonizzata.
SPC Section 4.3 - Contraindications The MAH was asked to harmonise Section 4.3, for which the following differences between SPCs needed to be evaluated:
Sezzjoni 4. 3 tal- SPC - Kontraindikazzjonijiet Il- MAH intalab jarmonizza s- Sezzjoni 4. 3, li għal liema kellhom jiġu evalwati d- differenzi bejn l - SPCs
- Monoamine oxidase inhibitors (MAOIs);
- Inibituri tal- Monoamine oxidase (MAOIs);
- Cardiovascular safety
- Sigurtà kardjovaskulari;
- Uncontrolled hypertension.
- Pressjoni għolja mhux ikkontrollata.
The MAH was of the view that all MAOIs should be contraindicated with venlafaxine.
Il- MAH kien tal- fehma li l- MAOIs kollha għandhom ikunu kontraindikati ma ’ venlafaxine.
However, the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.4 and Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Madankollu, is- CHMP qies li l- MAOIs irriversibbli mhux selettivi biss kellhom ikunu kontraindikati u li twissija qawwija fis- Sezzjoni 4. 4 u s- Sezzjoni 4. 5 tal- SPC għandhom ikunu suffiċjenti għall - MAOIs riversibbli.
The SPC was amended to reflect the CHMP position.
L- SPC ġie emendat biex jirrifletti l- pożizzjoni tas- CHMP.
A new study report was provided which concluded that the use of venlafaxine was not associated with an excess risk of sudden cardiac death compared with the SSRIs fluoxetine and citalopram or dusolepin in patients with depression or anxiety.
Ġie pprovdut rapport ta ’ studju ġdid li kkonkluda li l- użu ta ’ venlafaxine ma kienx assoċjat ma ’ riskju esaġerat ta ’ mewt ta ’ malajr minħabba attakk kardijaku meta kkumparat ma ’ SSRI fluexetine u citalopram jew dusolepin f’ pazjenti b’ dipressjoni jew ansjetà.
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.
Rigward is- sigurtà karjovaskulari, ġie miftiehem illi kontraindikazzjoni ma kinitx garantita u li kienet biżżejjed reviżjoni tal- kliem għas - Sezzjoni 4. 4.
16 The MAH was of the view that a contraindication in patients with uncontrolled hypertension was not warranted.
Il- MAH kien tal- fehma li ma kienx hemm bżonn ta ’ kontraindikazzjoni għall- pazjenti bi pressjoni għolja mhux ikkontrollata.
Given that strong warnings recommending the monitoring of blood pressure for all patients prior to the initiation of treatment were included in Section 4.4, the CHMP agreed that a contraindication in patients with uncontrolled hypertension was not warranted.
Minħabba f’ hekk, is - CHMP qabel li ma kienx hemm bżonn ta ’ kontraindikazzjoni fil- pazjenti bi pressjoni għolja mhux ikkontrollata.
SPC Section 4.4 - Special Warnings and Precautions for Use The MAH was asked to harmonise Section 4.4, for which the following differences between SPCs needed to be evaluated:
Sezzjoni 4. 4 tal- SPC – Twissijiet Speċjali u Prekawzjonijiet għall- Użu Il- MAH intalab jarmonizza s- Sezzjoni 4. 4, li għaliha kellhom jiġu evalwati d- differenzi li ġejjin bejn l- SPCs:
- the mentioning of reports of aggression in relation to starting and discontinuing treatment;
- li jissemmew rapporti ta ’ aggressjoni b’ rabta mal- bidu u t- twaqqif tat- trattament;
- treatment of children and adolescents under the age of 18, which was recommended by the CHMP in
- it- trattament ta ’ tfal u adolexxenti taħt it- 18- il sena, li ġie rrakkomandat mis- CHMP fl- 2005 li
2005 to be included in Section 4.4 of the SPC (Commission Decision of 19-VIII-2005); With regards to the aggression reports, it was agreed to introduce a wording to indicate that aggression may occur in patients receiving venlafaxine, under initiation, dose changes and discontinuation of treatment.
għandu jiġi inkluż fis- Sezzjoni 4. 4 tal- SPC (Deċiżjoni tal- Kummissjoni tad- 19- VIII- 2005); Fir- rigward tar- rapporti dwar l- aggressjoni, kien hemm qbil li tiddaħħal formolazzjoni tal- kliem li tindika li jista ’ jkun hemm aggressjoni minn pazjenti li jkunu qegħdin jingħataw venlafaxine, waqt il - bidu, it- tibdil fid- doża u t- twaqqif tat- trattament.
A warning on the use of Efexor depot in the treatment of children and adolescents under the age of 18 years was also agreed upon and introduced in Section 4.4.
Kien hemm qbil ukoll li hemm bżonn ta ’ twissija fuq l- użu ta ’ Efexor fit- trattament tat- tfal u l - adolexxenti ta ’ taħt it- 18- il sena u din ġiet introdotta fis- Sezzjoni 4. 4.
SPC Section 4.5 - Interaction with other medicinal products and other forms of interaction The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics, for which the following differences between SPCs needed to be evaluated:
16 Il- MAH intalab jarmonizza s- Sezzjoni 4. 5 fis- Sommarju tal- Karatterisiċi tal- Prodott, li għalihom ħtieġu li jiġu evalwati dawn id- differenzi bejn l- SPCs:
- monoamine oxidase inhibitors.
- inibituri tal- monoamine oxidase.
The MAH wished to maintain that all MAOIs should be contraindicated whereas the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Il- MAH xtaq li l- MAOIs kollha jibqgħu kontraindikati waqt li s- CHMP qies li għandhom jiġu kontraindikati biss il- MAOIs selettivi u riversibbli u li twissija qawwija fis- Sezzjoni 4. 5 tal- SPC għandha tkun biżżejjed għall- MAOIs riversibbli.
The SPC was amended according to the CHMP position.
L- SPC kien emendat skont il- pożizzjoni tas- CHMP.
In the harmonized text of Section 4.4 it is indicated that non-selective MAOIs should not be given concomitantly, and that reversible, selective MAOIs such as moclobemide are not recommended in combination with venlafaxine, due to the risk of serotonin syndrome.
Fit- test armonizzat tas- Sezzjoni 4. 4 hemm indikat li l- MAOIs mhux selettivi m’ għandhomx jingħataw fl- istess ħin, u l- użu ta ’ MAOIs selettivi riversibbli bħal moclobemide f’ kombinazzjoni ma ’ venlafaxine mhuwiex rakkomandat, minħabba r- riskju tas- sindromu tas- serotonin.
SPC Section 4.8 - Undesirable effects The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH’ s CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Sezzjoni 4. 8 tal- SPC – Effetti mhux mixtieqa Il- MAH intalab jidentifika d- differenzi bejn l- avvenimenti mhux mixtieqa elenkati fl- SPCs approvati fuq livell nazzjonali u s- CDS tal- MAH, u jorganizza s- Sezzjoni 4. 8 skont il- klassifikazzjoni tas - sistema tal- organi MedDRA.
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.
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.
Psychomotor restlessness was also added to the table of adverse reactions.
Mat - tabella tar- reazzjonijiet mhux mixtieqa żdiedet ukoll l- aġitazzjoni psikometrika.
Following review, chills, confusion, depersonalisation, headache, menstrual disorders, palpitations and pollakiuria were included in this table.
Wara reviżjoni ġew miżjuda kesħiet, konfużjoni, depersonalizzazzjoni, uġiegħ ta ’ ras, disturbi fil- menstruwazzjoni, palpitazzjonijiet u pollakurja ġew inklużi f’ din it- tabella.
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.
Il- MAH ma qabilx mal- formolazzjoni tal - kliem 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.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJI TAL- KARATTERISTIĊI TAL - PRODOTT, IT- TIKKETTA U L- FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- ambitu tar- riferiment kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketta,
labelling, package leaflet.
il- fuljett ta ’ tagħrif.
17
17 ANNESS III
19 SUMMARY OF PRODUCT CHARACTERISTICS
18 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Efexor depot and associated names (see Annex I) 37.5 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 75 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 150 mg hard prolonged-release capsules
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 150 mg kapsuli iebsin li jerħu l- mediċina bil - mod.
Hard prolonged-release capsule.
Kapsula iebsa li terħi l- mediċina bil- mod,
Treatment of major depressive episodes.
Għall- kura ta ’ episodji dipressivi maġġuri.
For prevention of recurrence of major depressive episodes.
Għall- prevenzjoni ta ’ rikorrenza ta ’ episodji dipressivi maġġuri.
Treatment of generalised anxiety disorder.
Kura ta ’ disturb ta ’ ansjetà ġeneralizzata.
Treatment of social anxiety disorder.
Kura ta ’ disturb ta ’ ansjetà soċjali.
Treatment of panic disorder, with or without agoraphobia.
Kura ta ’ disturb ta ’ paniku bi jew mingħajr agorafobija.
Major depressive episodes
Episodji dipressivi maġġuri
The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily.
Id- doża rakkomandata tal- bidu għal venlafaxine li jerħi bil- mod hi ta ’ 75 mg mogħtija darba kuljum.
Patients not responding to the initial 75 mg/ day dose may benefit from dose increases up to a maximum dose of 375 mg/ day.
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.
Dosage increases can be made at intervals of 2 weeks or more.
Iż- żidiet fid- dożaġġ jistgħu jsiru f’ intervalli ta ’ ġimagħtejn jew aktar.
If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.
Jekk ikun klinikament meħtieġ minħabba s- severità tas- sintomi, żidiet fid- doża jistgħu jsiru f’ intervalli aktar frekwenti, iżda mhux inqas minn 4 ijiem.
21 Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4).
Minħabba r- riskju ta ’ effetti avversi marbuta mad- doża, l- inkrementi fid- doża għandhom isiru biss wara evalwazzjoni klinika (ara sezzjoni 4. 4).
The lowest effective dose should be maintained.
Għandha tinżamm l- inqas doża effettiva.
Patients should be treated for a sufficient period of time, usually several months or longer.
Il- pazjenti għandhom ikunu kkurati għall- perjodu ta ’ żmien suffiċjenti, normalment diversi xhur jew iktar.
Treatment should be reassessed regularly on a case-by-case basis.
Il -
Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE).
20 kura għal perjodu itwal tista ’ tkun adattata wkoll għall- prevenzjoni ta ’ rikorrenza ta ’ episodji dipressivi maġġuri (MDE).
In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode.
Fil- biċċa l- kbira tal- każijiet, id- doża rakkomandata għall- prevenzjoni ta ’ rikorrenza ta ’ MDE hi l- istess bħal dik użata fl- episodju kurrenti.
Antidepressive medicinal products should continue for at least six months following remission.
Il- prodotti mediċinali kontra d- dipressjoni għandha titkompla għal mill- inqas sitt xhur wara tnaqqis fil- mard.
Generalised anxiety disorder
Disturb ta ’ ansjetà ġeneralizzata
The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily.
Id- doża tal- bidu rakkomandata għal venlafaxine li jerħi bil- mod hi ta ’ 75 mg mogħtija darba kuljum.
Patients not responding to the initial 75 mg/ day dose may benefit from dose increases up to a maximum dose of 225 mg/ day.
Madankollu, f’ pazjenti individwali li ma jkunux qed jirrispondu għad- doża tal- bidu ta ’ 75 mg/ kuljum, żidiet fid- doża sa doża massima ta ’ 225 mg/ kuljum jistgħu jiġu kkunsidrati.
Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4).
Minħabba r- riskju ta ’ effetti avversi marbuta mad- doża, l- inkrementi fid- doża għandhom isiru biss wara evalwazzjoni klinika (ara sezzjoni 4. 4).
Treatment should be reassessed regularly, on a case-by-case basis.
Il- kura għandha tkun evalwata mill- ġdid b’ mod regolari skond il- każ fuq bażi individwali.
Social anxiety disorder
Disturb ta ’ ansjetà soċjali
The recommended dose for prolonged-release venlafaxine is 75 mg given once daily.
Id- doża rakkomandata għal venlafaxine li jerħi bil- mod hi ta ’ 75 mg mogħtija darba kuljum.
There is no evidence that higher doses confer any additional benefit.
M’ hemm l- ebda evidenza li dożi ogħla jagħtu xi benefiċċju addizzjonali.
However, in individual patients not responding to the initial 75 mg/ day, increases up to a maximum dose of 225 mg/ day may be considered.
Pazjenti li ma jkunux qed jirrispondu għad- doża tal- bidu ta ’ 75 mg/ kuljum, jistgħu jibbenefikaw minn żidiet fid- doża sa doża massima ta ’ 225 mg/ kuljum.
Panic disorder
Disturb ta ’ paniku
It is recommended that a dose of 37.5 mg/ day of prolonged-release venlafaxine be used for 7 days.
Hu rakkomandat li doża ta ’ 37. 5 mg/ kuljum ta ’ venlafaxine li jerħi bil- mod tintuża għal 7 ijiem.
Dosage should then be increased to 75 mg/ day.
Id - dożaġġ għandu mbagħad jiżdied għal 75 mg/ kuljum.
Patients not responding to the 75 mg/ day dose may benefit from dose increases up to a maximum dose of 225 mg/ day.
Pazjenti li ma jkunux qed jirrispondu għal doża ta ’ 75 mg/ kuljum, jistgħu jibbenefikaw minn żidiet fid- doża sa doża massima ta ’ 225 mg/ kuljum.
Dosage increases can be made at intervals of 2 weeks or more.
Iż - żidiet fid- dożaġġ jistgħu jsiru f’ intervalli ta ’ ġimagħtejn jew aktar.
Use in elderly patients
L- użu f’ pazjenti anzjani
22 No specific dose adjustments of venlafaxine are considered necessary based on patient age alone.
L- ebda aġġustamenti speċifiċi fid- doża ta ’ venlafaxine m’ huma kkunsidrati li huma meħtieġa, ibbażat fuq l- età tal- pazjent biss.
However, caution should be exercised in treating the elderly (e. g., due to the possibility of renal impairment, the potential for changes in neurotransmitter sensitivity and affinity occurring with aging).
Madankollu, għandha tingħata attenzjoni fil- kura ta ’ l- anzjani (eż., minħabba l- possibbiltà ta ’ indeboliment renali, u l- potenzjal għal tibdil fis- sensittività u l- affinità tan - newrotrasmettituri li sseħħ minħabba l- età).
The lowest effective dose should always be used, and patients should be carefully monitored when an increase in the dose is required.
L- inqas doża effettiva għandha dejjem tintuża u l- pazjenti għandhom ikunu mmonitorjati bl- attenzjoni meta tkun meħtieġa żieda fid- doża.
Use in children and adolescents under the age of 18 years
21 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena
Venlafaxine is not recommended for use in children and adolescents.
Venlafaxine mhuwiex rakkomandat għall- użu fit- tfal u fl- adolexxenti.
Controlled clinical studies in children and adolescents with major depressive disorder failed to demonstrate efficacy and do not support the use of venlafaxine in these patients (see sections 4.4 and 4.8).
Studji kliniċi kkontrollati fit- tfal u fl- adolexxenti b’ disturb dipressiv maġġuri, naqsu li juru l- effikaċja u ma jappoġġjawx l- użu ta ’ venlafaxine f’ dawn il- pazjenti (ara sezzjonijiet 4. 4 u 4. 8).
The efficacy and safety of venlafaxine for other indications in children and adolescents under the age of 18 have not been established.
L- effikaċja u s- sigurtà ta ’ venlafaxine għal indikazzjonijiet oħrajn fit- tfal u fl- adolexxenti taħt it- 18- il sena ma kinux stabbiliti.
Use in patients with hepatic impairment
L- użu f’ pazjenti b’ indeboliment epatiku
In patients with mild and moderate hepatic impairment, in general a 50% dose reduction should be considered.
F’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat, b’ mod ġenerali għandu jiġi kkunsidrat tnaqqis ta ’ 50% fid- doża.
However, due to inter-individual variability in clearance, individualisation of dosage may be desirable.
Madankollu, minħabba l- varjabilità individwali fit- tneħħija f’ dawn il - pazjenti, jista ’ jkun hemm bżonn ta ’ l- individwalizzazzjoni tad- dożaġġ.
There are limited data in patients with severe hepatic impairment.
Hemm dejta limitata f’ pazjenti b’ indeboliment epatiku sever.
Caution is advised, and a dose reduction by more than 50% should be considered.
L- attenzjoni hi rakkomandata u tnaqqis fid- doża b’ iktar minn 50% għandu jkun ikkunsidrat.
The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment.
Il- benefiċċju potenzjali għandu jintiżen kontra r - riskju fil- kura ta ’ pazjenti b’ indeboliment epatiku sever.
Use in patients with renal impairment
L- użu f’ pazjenti b’ indeboliment renali
Although no change in dosage is necessary for patients with glomerular filtration rate (GFR) between 30-70 ml/ minute, caution is advised.
Għalkemm l- ebda bidla fid- dożaġġ mhi meħtieġa għal pazjenti b’ rata tal- filtrazzjoni glomerulari (GFR) bejn 30- 70 ml/ minuta, l- attenzjoni hi rakkomandata.
For patients that require haemodialysis and in patients with severe renal impairment (GFR < 30 ml/ min), the dose should be reduced by 50%.
Għal pazjenti li jkunu jeħtieġu l - emodijalisi u f’ pazjenti b’ indeboliment renali sever (GFR < 30 ml/ min), id- doża għandha titnaqqas b’ 50%.
Because of inter-individual variability in clearance in these patients, individualisation of dosage may be desirable.
Minħabba l- varjabilità individwali fit- tneħħija f’ dawn il- pazjenti, jista ’ jkun hemm bżonn ta ’ l- individwalizzazzjoni tad- dożaġġ.
Withdrawal symptoms seen on discontinuation of venlafaxine
Sintomi ta ’ meta tieqaf tieħu l- mediċina kienu osservati mat- twaqqif ta ’ venlafaxine
Abrupt discontinuation should be avoided.
It- twaqqif għal għarrieda għandu jkun evitat.
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).
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).
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Jekk iseħħu sintomi intollerabbli wara tnaqqis fid- doża jew mat- twaqqif tal- kura, allura t- tkomplija tal- kura b’ doża li għaliha ngħatat riċetta qabel tista ’ tkun ikkunsidrata.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Sussegwentement, it- tabib jista ’ jkompli jnaqqas id- doża, iżda b’ rata iktar gradwali.
It is recommended that venlafaxine prolonged-release capsules be taken with food, at approximately the same time each day.
Hu rakkomandat li kapsuli ta ’ venlafaxine li jerħu b’ mod immedjat, jittieħdu ma ’ l- ikel bejn wieħed u ieħor fl- istess ħin kuljum.
Capsules must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.
Il- kapsuli għandhom jinbelgħu sħaħ ma ’ xi likwidu, u m’ għandhomx jinqasmu, jitgħaffġu, jintmagħdu, jew jinħallu.
Patients treated with venlafaxine immediate-release tablets may be switched to venlafaxine prolonged-release capsules at the nearest equivalent daily dosage.
Il- pazjenti kkurati b’ pilloli ta ’ venlafaxine li jerħu b’ mod immedjat jistgħu jaqilbu għal kapsuli ta ’ venlafaxine li jerħu l- mediċina bil- mod, fl- eqreb dożaġġ ekwivalenti ta ’ kuljum.
For example, venlafaxine immediate-release tablets 37.5 mg twice daily may be switched to venlafaxine prolonged-release capsules 75 mg once daily.
Per eżempju, pilloli ta ’ venlafaxine ta ’ 37. 5 mg li jerħu b’ mod immedjat, darbtejn kuljum, jistgħu jkunu sostitwiti ma ’ kapsuli ta ’ venlafaxine ta ’ 75 mg li jerħu l- mediċina bil- mod, darba kuljum.
Individual dosage adjustments may be necessary.
Aġġustamenti individwali fid- dożaġġ jistgħu jkunu meħtieġa.
23 Venlafaxine prolonged-release capsules contain spheroids, which release the active substance slowly into the digestive tract.
Kapsuli ta ’ venlafaxine li jerħu l- mediċina bil- mod fihom sferojdi li jerħu l- mediċina bil- mod ġo l - apparat diġestiv.
The insoluble portion of these spheroids is eliminated and may be seen in faeces.
Il- porzjon li ma jinħallx ta ’ dawn l- isferojdi jiġi eliminat u jista ’ jkun osservat fl - ippurgar.
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.
22 Il- kura fl- istess ħin b’ inibituri irriversibbli ta ’ monoamine- oxidase (MAOIs) hi kontra- indikata minħabba r- riskju tas- sindrome ta ’ serotonin b’ sintomi bħal aġitazzjoni, tregħid, u ipertermija.
Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.
Venlafaxine m’ għandux jinbeda għal mill- inqas 14- il jum wara t- twaqqif tal- kura b’ MAOI irriversibbli.
Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see sections 4.4 and 4.5).
Venlafaxine għandu jitwaqqaf għal mill- inqas 7 ijiem qabel ma tinbeda l- kura bi kwalunkwe MAOI irriversibbli (ara sezzjonijiet 4. 4 u 4. 5).
Suicide/ suicidal thoughts or clinical worsening
Suwiċidju/ ħsibijiet suwiċidali jew l- aggravament tas- sitwazzjoni klinika
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide- related events).
Id- dipressjoni hi marbuta ma ’ żieda fir- riskju ta ’ ħsibijiet suwiċidali, ħsara li wieħed jagħmel lilu nnifsu u suwiċidju (avvenimenti marbuta ma ’ suwiċidju).
This risk persists until significant remission occurs.
Dan ir- riskju jippersisti sakemm iseħħ tnaqqis sinifikanti fil- mard.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Minħabba li t- titjib jista ’ ma jseħħx matul l- ewwel ftit ġimgħat jew aktar tal- kura, il- pazjenti għandhom ikunu mmonitorjati mill- qrib sakemm iseħħ dan it- itjib.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Hi esperjenza klinika ġenerali li r- riskju ta ’ suwiċidju jista ’ jiżdied fl- istadji bikrin ta ’ l- irkuprar.
Other psychiatric conditions for which venlafaxine is prescribed can also be associated with an increased risk of suicide-related events.
Kundizzjonijiet psikjatriċi oħrajn li għalihom tingħata riċetta għal venlafaxine, jistgħu jkunu assoċjati wkoll ma ’ żieda fir- riskju ta ’ avvenimenti marbuta mas- suwiċidju.
In addition, these conditions may be co-morbid with major depressive disorder.
Flimkien ma ’ dan, dawn il - kundizzjonijiet jistgħu jseħħu fl- istess ħin ma ’ disturb dipressiv maġġuri.
The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
L- istess prekawzjonijiet osservati fil- kura ta ’ pazjenti b’ disturb dipressiv maġġuri għandhom għalhekk ikunu osservati fil- kura ta ’ pazjenti b’ mard psikjatriku ieħor.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Pazjenti bi storja medika ta ’ avvenimenti marbuta mas- suwiċidju, jew dawk li juru grad sinifikanti ta ’ formazzjoni ta ’ ħsieb biex jitwettaq suwiċidju qabel il- bidu tal- kura, huma magħrufa li huma f’ riskju akbar ta ’ ħsibijiet suwiċidali jew attentati ta ’ suwiċidju, u għandhom jirċievu monitoraġġ b’ attenzjoni matul il- kura.
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.
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.
Close supervision of patients, and in particular those at high risk, should accompany drug therapy, especially in early treatment and following dose changes.
Superviżjoni mill- qrib ta ’ pazjenti, u b’ mod partikulari dawk f’ riskju għoli, għandha takkompanja t - terapija bil- mediċina speċjalment fl- istadju bikri tal- kura u wara xi tibdil fid- doża.
Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present.
Pazjenti (u persuni li jieħdu ħsieb il- pazjenti) għandhom ikunu mwissija dwar il- ħtieġa li jsir monitoraġġ għal kwalunkwe aggravament kliniku, imġiba jew ħsibijiet suwiċidali, u tibdil mhux tas- soltu fl- imġiba, u biex ifittxu parir mediku immedjatament jekk dawn is- sintomi jkunu preżenti.
Use in children and adolescents under 18 years of age
L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena
Efexor depot should not be used in the treatment of children and adolescents under the age of 18 years.
Efexor depot m’ għandux jintuża fil- kura ta ’ tfal u adoloxxenti ta ’ taħt it- 18- il sena.
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.
Imġiba marbuta mas- suwiċidju (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 adolexxenti li kienu kkurati b’ anti- dipressanti, meta mqabbla ma ’ dawk ikkurati bil- plaċebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Jekk, madankollu, fuq bażi tal- ħtieġa klinika, tittieħed deċiżjoni li tingħata l- kura, il- pazjent għandu jkun immonitorjat bl- attenzjoni għad- dehra ta ’ sintomi suwiċidali.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Flimkien ma ’ dan, m’ hemmx informazzjoni dwar is- sigurtà fit- tul fit- tfal u fl- adolexxenti fir- rigward tat- tkabbir, il- maturazzjoni u l - iżvilupp konoxxittiv u ta ’ l- imġiba.
24 Serotonin syndrome
Is- sindrome ta ’ serotonin