qanastek/EMEA-V3 huggingface dataset:
As a conclusion to the discussion, the following text was subsequently agreed between the CHMP and the applicant/ MAH to include the following: deletion of reference to section 4.3 for serotonin syndrome, deletion of “ other” and the addition of “ venlafaxine” in the text below.
Is- CHMP ħass li kontra- indikazzjoni hija aċċettabbli, minħabba l- influwenza marġinali fuq il- livelli ta ’ noradrenaline u serotonin u l- esperjenza ta ’ wara t- tqegħid fis- suq li teżisti sal- lum.
Pharmacodynamic interactions Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Bidliet patoloġiċi fl- għadd tad- demm L- applikant / Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq sostna li ma kien hemm l- ebda dejta li tindika li mirtazapine jiggrava l- kundizzjonijiet fejn jinbidel l- għadd tad- demm.
In addition, as with other SSRIs, co-administration with other serotonergic drugs active substances (L-tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St.
Minħabba l - inċidenza baxxa ħafna ta ’ l- iżjed kundizzjoni serja, jiġifieri l- agranuloċitożi (indipendentement mill - kwistjoni tal- kawżalità jew jekk taqbiżx l- inċidenza ta ’ sfond), din mhijiex kontra- indikazzjoni assoluta u m’ għandhiex tkun inkluża f’ sezzjoni 4. 3.
Therefore, the following wording on pharmacodynamic interactions for Section 4.5 of the SPC was recommended:
Rigward il- bidliet patoloġiċi fl- għadd tad- demm, is- CHMP ħass li l- kliem propost huwa aċċettabbli, fuq ir- rapport ta ’ meta- analiżi pprovdut fir- risposti ta ’ l- applikant/ Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq.
Pharmacodynamic interactions
SPC Sezzjoni 4. 5 Twissijiet speċjali u prekawzjonijiet għall- użu
- Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks
Barra minn hekk, is- CHMP kien ta ’ l - opinjoni li l- mekkaniżmu ta ’ l- interazzjoni tal- MAOIs ma ’ mirtazapine hu differenti mis- SSRIs.
after discontinuation of MAO inhibitor therapy.
In - numru baxx ta ’ rapporti wara t- tqegħid fis- suq tal- prodott lanqas ma jiġġustifikaw dan.
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors.
Għalhekk, kienet rakkomandata ż- żieda ta ’ cross reference għal sezzjoni 4. 3 tal- SPC f’ sezzjoni 4. 5 (wara l- kliem relatat ma ’ l- interazzjoni mal- MAOIs), b’ mod konformi mal- SPC armonizzat għas- SSRIs u konformi mal- SPC għal venlafaxine - SNRI.
- In addition, as with SSRIs, co-administration with other serotonergic active substances (L-
L- applikant / Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq qablu wkoll li jinkludu l- interazzjoni mal- MAOIs f’ sezzjoni 4. 3 tal- SPC:
tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St.
Barra minn hekk, bħal fil- każ tas- SSRIs, l- għoti fl- istess ħin ma ’ sustanzi attivi mediċini serotonerġiċi oħra (L- tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium u St.
John's Wort – Hypericum perforatum – preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4) Caution should be advised and a closer clinical monitoring is required when these drugs are combined with mirtazapine.
John' s Wort – Hypericum perforatum – preparazzjonijiet) jista ’ jwassal għal inċidenza ta ’ effetti assoċjati ma ’ serotonin 5- HT (sindromu tas- serotonin: ara Sezzjoni 4. 3 Kontra- indikazzjonijiet u sezzjoni 4. 4 Twissijiet Speċjali u Prekawzjonijiet Speċjali għall- Użu).
14
Interazzjonijiet farmakodinamiċi
- Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably
- Mirtazapine m’ għandux jingħata fl- istess ħin ma ’ inibituri MAO jew sa ġimagħtejn wara t- twaqqif
most antipsychotics, antihistamine H1 antagonists, opioids).
ta ’ terapija b’ inibitur MAO.
Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
Bl- istess mod għandhom jgħaddu madwar ġimagħtejn qabel ma l- pazjenti ttrattati b’ mirtazapine jiġu ttrattati b’ inibituri MAO.
- Mirtazapine may increase the CNS depressant effect of alcohol.
- Barra minn hekk, bħal fil- każ tas- SSRIs, l- għoti fl- istess ħin ma ’ sustanzi attivi serotonerġiċi oħra (L -
Patients should therefore be
tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium u St.
advised to avoid alcoholic beverages while taking mirtazapine. monitoring for signs of beginning serotonergic overstimulation maintained is warranted.
Għandha tintuża kawtela meta dawn il- prodotti mediċinali jiġu preskritti flimkien ma ’ mirtazapine.
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the
Il- pazjenti għalhekk għandhom
international normalized ratio (INR) in subjects treated with warfarin.
jingħataw parir sabiex jevitaw ix- xorb alkoħoliku waqt li jkunu qegħdin jieħdu mirtazapine.
As at a higher dose of mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
Ikun meħteġ li jsir monitoraġġ għall- possibilità ta ’ sinjali ta ’ bidu ta ’ iperstimulazzjoni serotonerġika
Additionally in Section 4.5 of the SPC, the CHMP considered it sufficient to state that Lithium and mirtazapine showed no pharmacokinetic interactions (last paragraph section 4.5) without further specifications.
Barra minn hekk f’ Sezzjoni 4. 5 tal- SPC, is- CHMP ħass li kien suffiċjenti li jiddikjara li l- Lithium u mirtazapine ma wrew l- ebda interazzjonijiet farmakokinetiċi (l- aħħar paragrafu ta ’ sezzjoni 4. 5) mingħajr iżjed speċifikazzjonijiet.
The general wording on absence of interactions should not be included.
Il- kitba ġenerali dwar in- nuqqas ta ’ interazzjonijiet m’ għandhiex tiġi inkluża.
Pharmacokinetic interactions.
Fl- aħħarnett, l- istudju dwar l- interazzjoni ta ’ cimetidine għandu jiġi inkluż f’ sezzjoni 4. 5 Interazzjonijiet farmakokinetiċi.
Therefore the following wording was recommended:
Għalhekk kienet rakkomandata l- kitba li ġejja:
- Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about
- Carbamazepine u phenytoin, li huma indutturi ta ’ CYP3A4, żiedu t- tneħħija ta ’ mirtazapine
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
b’ madwar darbtejn, li rriżulta fi tnaqqis ta ’ 60% u 45%, rispettivament, fil- konċentrazzjoni medja ta ’ mirtazapine fil- plasma.
When carbamazepine or any other inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased.
Meta carbamazepine jew kwalunkwe induttur ieħor tal - metaboliżmu epatiku (bħal rifampicin) jiġi miżjud ma ’ terapija b’ mirtazapine, id- doża ta ’ mirtazapine għandha mnejn ikollha tiġi miżjuda.
If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.
Jekk it- trattament bi prodott mediċinali bħal dan ma jitkompliex, jista ’ jkun neċessarju li titnaqqas id- doża ta ’ mirtazapine.
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma
- L- għoti ta ’ ketoconazole, li huwa inibitur qawwi ta ’ CYP3A4, żied il- livelli massimi fil- plasma
levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
u l- AUC ta ’ mirtazapine b’ madwar 40% u 50% rispettivament.
Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin or nefazodone.
Għandha tintuża kawtela meta wieħed jagħti mirtazapine fl- istess ħin ma ’ inibituri qawwija ta ’ CYP3Ar, inibituri tal- protease tal- HIV, antifungali azole, erythromycin jew nefazodone.
- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with
- Meta cimetidine (inibitur dgħajjef ta ’ CYP1A2, CYP2D6 u CYP3A4) jingħata ma ’
mirtazapine, the mean plasma concentration of mirtazapin may increase more than 50%.
mirtazapine, il- konċentrazzjoni medja fil- plasma ta ’ mirtazapine tista ’ tiżdied b’ aktar minn 50%.
Caution should be exercised and the dose may have to be decreased when co- administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, cimetidine or nefazodone.
Għandha tintuża kawtela u d- doża jista ’ jkun li jkollha titnaqqas meta mirtazapine jingħata flimkien ma ’ inibituri qawwija ta ’ CYP3A4, inibituri tal- protease tal- HIV, antifungali azole, erythromycin, cimetidine jew nefazodone.
- No significant pharmacokinetic interactions are expected between mirtazapine and other
- Mhumiex mistennija interazzjonijiet farmakokinetiċi sinifikanti bejn mirtazapine u sustanzi
psychotropic active substances because most psychotropic active substances are metabolized by multiple cytochrome P450 (CYP) iso-enzymes and one metabolic pathway will compensate for the other in case of inhibition of one or more CYP iso-enzymes.
psikotropiċi attivi oħra minħabba li l- maġġoranza tas- sustanzi psikotropiċi attivi jiġu metabolizzati minn diversi isoenzimi taċ- ċitokromu P450 (CYP) u passaġġ metaboliku wieħed jikkumpensa għall- ieħor f’ każ ta ’ inibizzjoni ta ’ waħda jew aktar mill- isoenzimi CYP.
Mirtazapine does not significantly inhibit or induce CYP iso-enzymes.
Mirtazapine ma jinibixxix u ma jinduċix b’ mod sinifikanti l- isoenzimi CYP.
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent
- L- istudji ta ’ l- interazzjoni ma indikaw ebda effetti farmakokinetiċi sinifikanti fuq it- trattament
treatment of mirtazapine with paroxetine, amitriptyline, or risperidone or lithium.
simultanju ta ’ mirtazapine ma ’ paroxetine, amitriptyline, jew risperidone jew lithium.
A single dose of mirtazapine does not result in any acute effect on the pharmacokinetics of lithium at steady state.
Doża waħda ta ’ mirtazapine ma tirriżulta f’ ebda effett akut fuq il- farmakokinetiċi tal- lithium fl- istat fiss.
SPC 4.8 Undesirable Effects
18 SPC 4. 8 Effetti mhux mixtieqa
During the last PSUR period (01 Sep 2004 to 01 Sep 2007), 36 cases of hyponatraemia and 8 cases of SIADH were reported for mirtazapine (Remeron).
Matul l- aħħar perjodu tal- PSUR (01 ta ’ Settembru 2004 sal- 1 ta ’ Settembru 2007), ġew irrappurtati 36 każ ta ’ iponatremija u 8 każi ta ’ SIADH għal mirtazapine (Remeron).
Accordingly hyponatraemia and SIADH are already described under 4.4 Special warnings.
Għaldaqstant l- iponatremija u s - SIADH huma diġà deskritti taħt 4. 4 Twissijiet speċjali.
For consistency, the CHMP considered that these undesirable effects should also be stated under 4.8 (Undesirable Effects).
Għall- konsistenza, is- CHMP ħass li dawn l - effetti mhux mixtieqa jiġu msemmija wkoll taħt 4. 8 (Effetti mhux mixtieqa).
This proposal was adopted by the applicant/ MAH and the issue was resolved.
Din il- proposta ġiet adottata mill- applikant/ Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- kwistjoni kienet solvuta.
Package Leaflet
Fuljett ta ’ Tagħrif
The following amendments to the PIL were recommended, in line with the changes made to the SPC.
Kienu rakkomandati l- emendi li ġejjin fil- PIL, b’ mod konformi mal- bidliet magħmula fl- SPC.
BEFORE YOU TAKE REMERON
QABEL MA TIEĦU REMERON
Limited experience with Remeron administration to pregnant women does not indicate an increased risk.
Esperjenza limitata bl- għoti ta ’ Remeron lil nisa tqal ma tindikax riskju akbar.
However, caution should be exercised when used during pregnancy.
Madankollu, għandha tintuża kawtela meta jintuża waqt it- tqala.
Do not take Remeron while you are pregnant.
Tiħux Remeron meta inti tqila.
Despite this, in special cases your doctor may prescribe Remeron for you because it may be in the best interest of you and your child.
Minkejja dan, f’ każijiet speċjali, it- tabib tiegħek jista ’ jordnalek Remeron minħabba li jista ’ jkun fl- aħjar interess tiegħek u tat- tarbija.
If you are taking Remeron and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Remeron.
Jekk qed tieħu Remeron u tinqabad tqila jew qed tippjana biex tinqabad tqila, staqsi lit- tabib tiegħek jekk tistax tkompli tieħu Remeron.
Ask your doctor whether you can breast-feed, while taking Remeron.
Staqsi lit- tabib tiegħek jekk tistax tredda ’, waqt li tkun qed tieħu Remeron.
BEFORE YOU TAKE REMERON Take care when taking Remeron in combination with:
QABEL MA TIEĦU REMERON Oqgħod attent meta tieħu Remeron flimkien ma ’:
• antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St.
• antidipressanti bħal SSRIs, venlafaxine u L- tryptophan jew triptans (użati biex jikkuraw l - emigranja), tramadol (joqtol l- uġigħ), linezolid (antibijotiku), lithium (użat għat- trattament ta ’ xi kundizzjonijiet psikjatriċi) u preparazzjonijiet tas- St.
Johns Wort – Hypericum perforatum preparations (a herbal remedy for depression).
Johns Wort – Hypericum perforatum (rimedju mill- ħxejjex għad- depressjoni).
In very rare cases Remeron alone or the combination of Remeron with these medicines, can lead to a so-called serotonin syndrome.
F’ każijiet rari ħafna, Remeron waħdu jew it- taħlita ta ’ Remeron ma ’ dawn il- mediċini, jistgħu jwasslu għall- hekk imsejjaħ sindromu tas - serotonin.
Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
Xi wħud mis- sintomi ta ’ dan is- sindromu huma: deni mingħajr spjegazzjoni, għaraq, żieda fir- rata tal- qalb, dijarea, kontrazzjonijiet (bla kontroll) tal- muskoli, rogħda, riflessi attivi żżejjed, irrekwitezza, bidliet fil- burdata u telfien mis- sensi.
If you get a combination of these symptoms, talk to your doctor immediately.
Jekk ikollok taħlita ta ’ dawn is - sintomi, kellem lit- tabib tiegħek immedjatament.
The CHMP considered that the proposed wording under bullet point a and b were acceptable.
Is- CHMP ħass li l- kitba proposta taħt il- punti bullet a u b kienet aċċettabbli.
A warning concerning the use during pregnancy and the possible risk of withdrawal effects on the newborn were recommended to be included in the PIL.
Ġie rakkomandat li fil - PIL tiddaħħal twissija dwar l- użu waqt it- tqala u r- riskju possibbli ta ’ effetti ta ’ l- irtirar fuq it- tarbija li titwieled.
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJU( I) TAL- KARATTERISTIĊI TAL - PRODOTT, IT- TIKKETTI U L- FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- riferiment kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketti, il -
labelling, package leaflet and Module 3.
fuljett ta ’ tagħrif u l- Modulu 3.
- the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the
- is- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketti, il- fuljett ta ’ tagħrif u l- Modulu 3 proposti mid -
Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ġew evalwati fuq il- bażi tat- dokumentazzjoni ppreżentata u d- diskussjoni xjentifika fi ħdan il- Kumitat,
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Remeron and associated names (see Annex I).
is- CHMP irrakkomanda l- emenda ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketti u l- fuljett ta ’ tagħrif għalihom huma ppreżentati fl- Anness III, għal Remeron u l- ismijiet assoċjati (ara Anness I).
16 ANNEX III
20 ANNESS III
17 SUMMARY OF PRODUCT CHARACTERISTICS
21 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Remeron and associated names (see Annex I) 15 mg orodispersible tablets Remeron and associated names (see Annex I) 30 mg orodispersible tablets Remeron and associated names (see Annex I) 45 mg orodispersible tablets
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 15 mg Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 30 mg Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 45 mg
Each Remeron 15 mg orodispersible tablet contains 15 mg of mirtazapine.
Kull pillola li tinħall fil- ħalq Remeron 15 mg fiha 15 mg ta ’ mirtazapine.
Each Remeron 30 mg orodispersible tablet contains 30 mg of mirtazapine.
Kull pillola li tinħall fil- ħalq Remeron 30 mg fiha 30 mg ta ’ mirtazapine.
Each Remeron 45 mg orodispersible tablet contains 45 mg of mirtazapine.
Kull pillola li tinħall fil- ħalq Remeron 45 mg fiha 45 mg ta ’ mirtazapine.
Each Remeron 15 mg orodispersible tablet contains 4.65 mg aspartame and 28 mg sucrose.
Kull pillola li tinħall fil- ħalq Remeron 15 mg fiha 4. 65 mg aspartame u 28 mg zokkor tal- kannamieli.
Each Remeron 30 mg orodispersible tablet contains 9.30 mg aspartame and 56 mg sucrose.
Kull pillola li tinħall fil- ħalq Remeron 30 mg fiha 9. 30 mg aspartame u 56 mg zokkor tal- kannamieli.
Each Remeron 45 mg orodispersible tablet contains 13.95 mg aspartame and 84 mg sucrose.
Kull pillola li tinħall fil- ħalq Remeron 45 mg fiha 13. 95 mg aspartame u 84 mg zokkor tal- kannamieli.
Orodispersible tablet.
Pillola li tinħall fil- ħalq
15 mg orodispersible tablet:
Pillola li tinħall fil- ħalq ta ’ 15 mg:
Round, white, standard bevelled-edge, coded with ‘ TZ/ 1’ on one side.
Tonda, bajda, bit- tarf immullat standard, immarkata b’ kodiċi TZ/ 1fuq naħa waħda.
30 mg orodispersible tablet:
Pillola li tinħall fil- ħalq ta ’ 30 mg:
Round, white, standard bevelled-edge, coded with ‘ TZ/ 2‘ on one side.
Tonda, bajda, bit- tarf immullat standard, immarkata b’ kodiċi TZ/ 2fuq naħa waħda.
45 mg orodispersible tablet:
Pillola li tinħall fil- ħalq ta ’ 45 mg:
Treatment of episodes of major depression.
Episodji ta ’ dipressjoni qawwija.
Adults The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg.
Adulti Id- doża effettiva ta ’ kuljum hija bejn 15 u 45 mg; id- doża inizzjali hija 15 jew 30 mg.
Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment.
Mirtazapine jibda juri l- effetti tiegħu ġeneralment wara 1- 2 ġimgħat ta ’ trattament.
Treatment with an adequate dose should result in a positive response within 2-4 weeks.
Trattament b’ doża adegwata għandu jirriżulta f’ rispons pożittiv f’ 2- 4 ġimgħat.
With an insufficient response, the dose can be increased up to the maximum dose.
B’ rispons insuffiċjenti, d- doża tista tiżdied sad- doża massima.
If there is no response within a further 2-4 weeks, then treatment should be stopped.
Jekk ma jkunx hemm rispons fi żmien 2- 4 ġimgħat oħra, it- trattament għandu jitwaqqaf.
Elderly The recommended dose is the same as that for adults.
Anzjani Id- doża rrakkomandata hija l- istess bħal tal- adulti.
In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
F’ pazjenti anzjani żieda fid- doża għandha ssir b’ superviżjoni bir- reqqa sabiex wieħed jara reazzjoni sodisfaċenti u sikura.
Children and adolescents under the age of 18 years Remeron should not be used in children and adolescents under the age of 18 years (see section 4.4).
Tfal u adoloxxenti taħt l- eta` ta ’ 18- il sena Remeron m’ għandux jintuża fi tfal u addoloxxenti taħt l- eta` ta ’ 18- il sena (ara sezzjoni 4. 4).
19 Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
23 Indeboliment renali It- tneħħija ta ’ mirtazapine jista jkun imnaqqas f’ pazjenti b’ indeboliment renali moderata għal qawwija (tneħħija ta ’ creatinine < 40 ml/ min).
This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
Dan għandu jingħata kunsiderazzjoni meta Remeron jiġi miktub lil pazjenti ta ’ din il- kategorija (ara sezzjoni 4. 4).
Hepatic impairment The clearance of mirtazapine may be decreased in patients with hepatic impairment.
Indeboliment epatiku It- tneħħija ta ’ mirtazapine jista jkun imnaqqas f’ pazjenti b’ indeboliment epatika.
This should be taken into account when prescribing Remeron to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4).
Dan għandu jingħata kunsiderazzjoni meta Remeron jiġi miktub lil pazjenti ta ’ din il- kategorija, partikolarment b’ ineboliment epatiku qawwi, minħabba li pazjenti b’ indeboliment epatku ma ġewx investigati (ara sezzjoni 4. 4).
Mirtazapine has an elimination half-life of 20-40 hours and therefore Remeron is suitable for once daily administration.
Iż- żmien li jieħu mirtazapine sabiex jinżel għal nofs il- valur oriġinali tiegħu hu ta ’ 20- 40 siegħa u għalhekk Remeron huwa adattat għal amministrazzjoni ta ’ darba kuljum.
It should be taken preferably as a single night-time dose before going to bed.
Preferibilment għandu jittieħed bħala doża waħdanija bil- lejl qabel l- irqad.
Remeron may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night).
Remeron jista jingħata f’ żewġ dożi maqsuma (darba filgħodu u darba filgħaxija, id- doża ogħla għanda tingħata filgħaxija).
The tablets should be taken orally.
Il- pillola għanda tittieħed mill- ħalq.
The tablet will rapidly disintegrate and can be swallowed without water.
Il- pillola tinħall malajr u tista tinbela ’ mingħajr ilma.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Pazjenti b’ depressjoni għandhom jiġu kkurati għal perijodu suffiċjenti ta ’ mill- anqas 6 xhur biex ikun żgurat li huma ma baqgħalhomx sintomi.
It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).
Huwa rrakkomandat illi t- trattament b’ mirtazapine jitwaqqaf b’ mod gradwali sabiex jiġu evitati sintomi ta ’ rtirar (ara sezjoni 4. 4).
Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
L- użu ta ’ mirtazapine flimkien ma ’ impedituri ta 'monoamine oxidase (MAO) (ara sezzjoni 4. 5).
Use in children and adolescents under 18 years of age Remeron should not be used in the treatment of children and adolescents under the age of 18 years.
Użu fit- tfal u addoloxxenti taħt l- eta` ta ’ 18- il sena Remeron m’ għandux jintuża fit- trattament tat- tfal u addoloxxenti taħt l- eta` ta ’ 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.
Imġieba relatata ma ’ suwiċidju (attentat ta ’ suwiċidju u ħsibijiet suwiċidali), u ostilita` (il- biċċa l- kbira l - aggressjoni, imġieba antagonistika u rabja) kienu osservati iktar frekwentement fil- provi kliniċi fi tfal u addoloxxenti trattati bl- anti- depressanti pparagunati ma ’ dawk trattati 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 xorta waħda tittieħed deċiżjoni, ibbażata fuq bżonn kliniku, sabiex jingħata trattament, il- pazjent għandu jiġi segwit bir- reqqa għal apparizzjoni ta ’ sintomi suwiċidali.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Barra minn hekk, hemm nuqqas ta ’ tagħrif dwar sikurezza fit- tul fi tfal u addoloxxenti konċernanti tikbir, maturazzjoni u żvilupp konoxxittiv u tal - imġiba.
Suicide/ suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide- related events).
Suwiċidju/ ħsibijiet suwiċidali jew klinikament tmur għall- agħar Id- dipressjoni hija assoċjata ma ’ riskju ikbar ta ’ ħsibijiet suwiċidali, li tweġġa lilek innifsek u suwiċidju (eventi relatati ma ’ s- suwiċidju).
This risk persists until significant remission occurs.
Dan ir- riskju jippersisti sakemm ikun hemm taffija sinjifikanti.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Peress illi t- titjieb jista jdum ma jseħħ, fl- ewwel ġimgħat jew iżjed tat- trattament, il - pazjenti għandhom jiġu segwiti bir- reqqa sakemm iseħħ dan it- titjieb.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Hija esperjenza klinika ġenerali illi r- riskju ta ’ suwiċidju jista jiżdied fl- istadji inizjali ta ’ rkupru.
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 b’ passat ta ’ eventi relatati mas- suwiċidju jew dawk li juru grad sinjifikattiv ta ’ ideat suwiċidali qabel ma jinbeda t- trattament huma magħrufa li jkunu f’ riskju ikbar ta ’ ħsibijiet suwiċidali jew attentati suwiċidali, u għandhom jiġu mmonitorjati bir- reqqa waqt it- trattament.
A meta-analysis of placebo- controlled clinical trials of antidepressants 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 kontrollati bi plaċebo ta ’ mediċinali anti- depressanti f’ adulti b’ mard psikjatriku wera riskju ikbar ta ’ imġieba suwiċidali b’ anti- depressanti meta pparagunat ma ’ plaċebo f’ pazjenti ta ’ taħt il- 25 sena.
Close supervision of patients and in particular those at high risk should accompany therapy with antidepressants especially in early treatment and following dose changes.
Superviżjoni bir- reqqa f’ pazjenti b’ mod speċjali f’ dawk b’ riskju għoli għandu jakkompanja l- bidu tat - trattament u wara tibdil fid- dożi.
Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or
Pazjenti (u persuni li jieħdu ħsieb il- pazjenti) għandhom jiġu imwissija dwar il- bżonn ta ’ monitoraġġ għal tiħżin kliniku, imġieba jew ħsibijiet suwiċidali u bdil insolitu fl- imġieba u għandu jintalab parir mediku immedjatament jekk jippreżentaw ruħhom dawn is - sintomi.
With regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Remeron orodispersible tablets should be given to the patient.
24 Għar- rigward tal- possibilita` ta ’ suwiċidju, b’ mod partikolari fil- bidu tat- trattament, għanda tingħata kwantita` limitata ta ’ pilloli Remeron li jinħallu fil- ħalq lill- pazjent.
Bone marrow depression Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Remeron.
Dipressjoni tal- mudullun tal- għadam Dipressjoni tal- mudullun tal- għadam, li ssoltu jippreżenta ruħu bħala granuloċitopenija jew agranuloċitożi, ġie rrapurtat waqt trattament b’ Remeron.
Reversible agranulocytosis has been reported as a rare occurrence in clinical studies with Remeron.
Agranuloċitożi reversibbli ġie rrapurtat bħala okkorrenza rari fi studji kliniċi b’ Remeron.
In the postmarketing period with Remeron very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal.
Fil- perijodu ta ’ wara t- tqegħid fuq is- suq b’ Remeron ġew irrapurtati każijiet rari ħafna ta ’ agranuloċitożi, fil- parti l- kbira tagħhom reversibbli imma f’ x każijiet fatali.
Fatal cases mostly concerned patients with an age above 65.
Każijiet fatali kkonċernaw l- aktar pazjenti ta ’ eta` ‘ l fuq minn 65.
The physician should be alert for symptoms like fever, sore throat, stomatitis or other signs of infection; when such symptoms occur, treatment should be stopped and blood counts taken.
It- tabib għandu jkun attent għal sintomi bħal deni, uġigħ fil- griżmejn, stomatite jew sinjali oħrajn ta ’ infezzjoni; meta jseħħu dawn is- sintomi, t- trattament għandu jitwaqqaf u għandu jittieħed għadd tad- demm.
Jaundice Treatment should be discontinued if jaundice occurs.
Suffejra It- trattament għandu jitwaqqaf jekk tiżviluppa s- suffejra.
Conditions which need supervision Careful dosing as well as regular and close monitoring is necessary in patients with: – epilepsy and organic brain syndrome:
Kundizzjonijiet li għandhom bżonn ta ’ superviżjoni Dożaġġ b’ attenzjoni kif ukoll monitoraġġ bir- reqqa huwa neċessarju f’ pazjenti b ’: – epilessija u organic brain syndrome:
Although clinical experience indicates that epileptic seizures are rare during mirtazapine treatment, as with other antidepressants, Remeron should be introduced cautiously in patients who have a history of seizures.
Għalkemm esperjenza klinika indikat li attakki puletiċi epilettiċi huma rari waqt trattament b’ mirtazapine, bħal b’ anti- depressanti oħrajn, Remeron għandu jiġi introdott b’ attenzjoni f’ pazjenti li għandhom passat ta ’ attakki pupletiċi.
Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency – hepatic impairment:
It - trattament għandu jitwaqqaf f’ pazjent li jiżviluppa attakki pupletiċi, jew fejn hemm żieda fi frekwenza ta ’ attakki pupletiċi. – indeboliment epatiku:
Following a single 15 mg oral dose of mirtazapine, the clearance of mirtazapine was approximately 35% decreased in mild to moderate hepatically impaired patients, compared to subjects with normal hepatic function.
Wara doża orali waħda ta ’ 15 mg ta ’ mirtazapine, it- tneħħija ta ’ mirtazapine kien imnaqqas b’ madwar 35% f’ pazjenti bi ftit indeboliment epatiku għal moderata pparagunati ma ’ suġġetti b’ funzjoni epatika normali.
The average plasma concentration of mirtazapine was about 55% increased. – renal impairment:
Il- konċentrazzjoni medja tal- plażma ta ’ mirtazapine żdiedet b’ madwar 55%. – indeboliment renali:
Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance < 40 ml/ min) and severe (creatinine clearance ≤ 10 ml/ min) renal impairment the clearance of mirtazapine was about 30% and 50% decreased respectively, compared to normal subjects.
Wara doża orali waħda ta ’ 15 mg ta ’ mirtazapine, f’ pazjenti b’ indeboliment renali moderata (tneħħija ta ’ creatinine < 40 ml/ min) u qawwija (tneħħija ta ’ creatinine ≤10 ml/ min) it- tneħħija ta ’ mirtazapine kien imnaqqas b’ madwar 30% u 50% rispettivament pparagunati ma ’ suġġetti normali.
The average plasma concentration of mirtazapine was about 55% and 115 %increased respectively.
Il- konċentrazzjoni medja tal- plażma ta ’ mirtazapine żdiedet b’ madwar 55% u 115% rispettivament.
No significant differences were found in patients with mild renal impairment (creatinine clearance < 80 ml/ min) as compared to the control group. – cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarction, where normal precautions should be taken and concomitant medicines carefully administered. – low blood pressure. – diabetes mellitus:
Ma nstabux differenzi sinjifikanti f’ pazjenti b’ indeboliment renali ħafif (tneħħija ta ’ cretainine < 80 ml/ min) meta pparagunati mal- grupp tal - kontroll. – mard kardijaku bħal disturbi tal- konduzzjoni, angina pectoris u infart mijokardjali riċenti, fejn għandhom jittieħdu prekawzjonijiet normali u mediċini konkomitanti għandhom jiġu amministrati b’ attenzjoni. – pressjoni baxxa fid- demm – dijabete mellitus:
In patients with diabetes, antidepressants may alter glycaemic control.
F’ pazjenti bid- dijabete, l- antidipressanti jistgħu jalteraw il- kontroll glikemiku.
Insulin and/ or oral hypoglycaemic dosage may need to be adjusted and close monitoring is recommended.
Jista jkun hemm bżonn ta ’ aġġustament tad- dożi tal- insulina u/ jew ipoglikemiku orali u huwa rrakkomandat il- monitoraġġ mill- qrib.
Like with other antidepressants, the following should be taken into account: – Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified. – When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase.
Bħal b’ antidipressanti oħrajn, wieħed għandu jikkunsidra s- segwenti: – Jista jkun hemm tiħżin ta ’ sintomi psikotiċi meta anti- dipressanti huma amministrati lil pazjenti bi skiżofrenja jew disturbi psikotiċi oħrajn; ħsibijiet paranojiċi jistgħu jiġu intensifikati. – Meta qed tiġi ttrattata l- fażi dippressiva ta ’ diżordni bipolari, din tista tiġi trasformata fil- fażi manika.
Patients with a history of mania/ hypomania should be closely monitored.
Pazjenti b’ passat ta ’ manija/ ipomanija għandhom ikunu monitorati bir- reqqa.
Mirtazapine should be discontinued in any patient entering a manic phase. – Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms.
Mirtazapine għandu jitwaqqaf f’ pazjenti li jidħlu fil- fażi manika. – Għalkemm Remeron mhux vizzjuż, esperjenza ta ’ wara l- tqegħid fuq is- suq turi li terminazzjoni f’ daqqa tat- trattament wara amministrazzjoni għal tul ta ’ żmien kultant jista jwassal għal sintomi tal- irtirar.
The majority of withdrawal reactions are mild and self-limiting.
Il- maġġoranza tar- reazzjonijiet tal- irtirar huma ħfief u limitati fihom infushom.
Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported.
Fost is- sintomi ta ’ rtirar varji li ġew rrapurtati l- iktar frekwenti kien hemm sturdament, aġitazzjoni, anzjeta`, uġigħ ta ’ ras u nawsja.
Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease.
Anke jekk dawn ġew irrapurtati bħala sintomi ta ’ rtirar, għandu jiġi rejalizzat illi dawn is- sintomi jistgħu jkunu relatati mal- marda fl - isfond.
As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually.
Kif avżat f’ sezzjoni 4. 2, huwa rrakkomandat illi t- trattament b’ Mirtazapine għandu jitwaqqaf b’ mod gradwali. – Għanda tingħata attenzjoni f’ pazjenti b’ disturbi ta ’ micturition bħal ipertrofija tal- prostata u f’ pazjenti glawkoma akuta narrow- angle u żieda fil- pressjoni intra- okulari (għalkemm il -
21 – Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity). – Akathisia/ psychomotor restlessness:
25 possibilita` ta ’ problemi b’ Remeron hija żgħira minħabba li l- attivita` antikolinerġenika hija dgħajfa ħafna). – Akatisja / nuqqas ta ’ kwiet psikomutur:
The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
L- użu ta ’ antidepressanti ġie assoċjat ma ’ l- iżvilupp ta ’ akatisja, ikkaratterizzata b’ mod suġġettiv minn nuqqas ta ’ kwiet li ma jagħtix pjaċir jew ta’ dwejjaq u bżonn ta ’ tħarrik spiss akkumpanjat minn nuqqas ta ’ abbiltà li wieħed ipoġġi bilqegħda jew ma jitħarrikx.
This is most likely to occur within the first few weeks of treatment.
Dan x’ aktarx li jseħħ l- aktar fl- ewwel ftit ġimgħat ta ’ kura.
In patients who develop these symptoms, increasing the dose may be detrimental.
F’ pazjenti li jiżviluppaw dawn is- sintomi, żieda fid- doża tista ’ tkun ta ’ ħsara.
Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine.
Iponatrimija Iponatrimija, probabbilment minħabba sekrezzjoni mhux adattata ta ’ l- ormon antidijuretiku (SIADH), ġiet irrappurtata b’ mod rari bl- użu ta ’ mirtazapine.
Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia.
Għandha tintuża attenzjoni f’ pazjenti li qegħdin f’ riskju, bħal pazjenti anzjani jew pazjenti li fl- isess ħin qed jiġu kkurati b’ mediċini magħrufa li jikkawżaw iponatrimija.
Serotonin syndrome Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5).
Serotonin syndrome Interazzjoni ma ’ sustanzi attivi serotonerġiċi: jista jseħħ serotonin syndrome meta serotonin reuptake inhibitors selettivi (SSRIs) jingħataw f’ kumbinazzjoni ma ’ sustanzi attivi serotonerġiċi oħrajn (ara sezzjoni 4. 5).
Symptoms of serotonin syndrome may be hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
Sintomi ta ’ serotonin syndrome jistgħu jkunu ipertermija, riġidita`, instabilita` awtonomika possibilment bi tmewwiġ rapidu tas- sinjali vitali, bdil fl- istat mentali li jista ’ jinkludi konfużjoni, irritabilita` u aġitazzjoni estrema li twassal għal delirju u koma.
From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Remeron alone (see section 4.8).
Minn esperjenza wara t - tqegħid fuq is- suq, jidher illi serotonin syndrome iseħħ rarament ħafna f’ pazjenti trattati b’ Remeron waħdu (ara sezzjoni 4. 8).
Elderly patients Elderly patients are often more sensitive, especially with regard to the undesirable effects of antidepressants.
Pazjenti anzjani Ħafna drabi, pazjenti anzjani jkunu iktar sensittivi, b’ mod speċjali għar- rigward tal- effetti mhux mixtieqa ta ’ l- antidipressanti.
During clinical research with Remeron, undesirable effects have not been reported more often in elderly patients than in other age groups.
Waqt riċerki kliniċi b’ Remeron, ma ġewx irrapurtati effetti mhux mixtieqa iktar frekwenti f’ pazjenti anzjani milli pazjenti fi gruppi ta ’ etajiet oħrajn.
Sucrose Remeron contains sugar spheres, containing sucrose.
Zokkor tal- kannamieli Remeron fih sferi taz- zokkor li fihom zokkor tal- kannamieli.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fruttosju, malassorbiment ta ’ glukows- galaktosju jew insuffiċjenza ta ’ sucrase - isomaltase m’ għandhomx jieħdu din il- mediċina.
Aspartame Remeron contains aspartame, a source of phenylalanine.
Aspartame Remeron fih l- aspartame li huwa sors ta ’ fenilalanin.
It may be harmful for patients with phenylketonuria.
Kull pillola ta ’ 15 mg, 30 mg u 45 mg mirtazapine tikkorispondi għal 2. 6 mg, 5. 2 mg u 7. 8 mg fenilalanin rispettivament, Jista jkun ta ’ ħsara għal pazjenti b’ fenilketonurja.
- Mirtazapine should not be administered concomitantly with MAO inhibitors or within two
- Mirtazapine m’ għandiex tiġi amministrata b’ mod konkomitanti ma ’ inibituri MAO jew fi żmien
weeks after discontinuation of MAO inhibitor therapy.
ġimgħatejn minn meta tkun twaqqfet terapija ta ’ inibituri MAO.
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see section 4.3).
Bl- oppost, għandhom jitħallew ġimgħatejn minn meta pazjenti kienu trattati b’ mirtazapine biex jiġu trattati b’ inibituri MAO (ara sezzjoni 4. 3).
In addition, as with SSRIs, co-administration with other serotonergic active substances (L- tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St.
Barra minn hekk, bħal b’ SSRIs, ko- amministrazzjoni ma ’ sustanzi attivi serotonerġiċi oħrajn (L- tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, litju u St.
John’ s Wort – Hypericum perforatum – preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4).
John’ s Wort – Hypericum perforatum – preparazzjonijiet) jista ’ jwassal għal inċidenza ta ’ effetti assoċċjati ma ’ serotonin (serotonin syndrome: ara sezzjoni 4. 4).
Caution should be advised and a closer clinical monitoring is required when these active substances are combined with mirtazapine.
Għandha tiġi mwissija l- attenzjoni u hemm bżonn ta ’ monitoraġġ kliniku iktar bir- reqqa meta dawn is- sustanzi attivi huma kkumbinati ma ’ mirtazapine.
- Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives
- Mirtazapine tista żżid il- proprjetajiet sedattivi ta ’ benzodiazepines u sedattivi oħrajn
(notably most antipsychotics, antihistamine H1 antagonists, opioids).
(notevolment ħafna mill- antisikotiċi, opioids anti- istaminiċi H1- antagonistiċi).
Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
Għanda tintuża kawtela meta dawn il- prodotti mediċinali huma preskritti flimkien mal- mirtazapine.
- Mirtazapine may increase the CNS depressant effect of alcohol.
- Mirtazapine tista żżid l- effett dippressanti CNS tal- alkoħol.
Patients should therefore be
Għalhekk il- pazjenti għandhom jiġu
advised to avoid alcoholic beverages while taking mirtazapine.
imwissija sabiex jevitaw xorb alkoħoliku waqt li qed jieħdu mirtazapine.
22
26
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the
- Mirtazapine f’ doża ta ’ 30 mg darba kuljum ikkawżat żieda żgħira imma statistikament
international normalized ratio (INR) in subjects treated with warfarin.
sinjifikanti fir- razzjon normalizzat internazzjonali (INR) f’ suġġetti ttrattati b’ warfarin.
As at a higher dose of mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
Minħabba l- fatt illi b’ doża ikbar ta ’ mirtazapine ma jistax jiġi eskluż effett iktar pronunċat, huwa avviżabbli illi l- INR jiġi monitorat fil- każ ta ’ trattament konkomitanti ta ’ warfarin ma ’ mirtazapine.
- Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about
- Carbamazepine u phenytoin, indutturi CYP3A4, żiedu t- tneħħija ta’ mirtazapine madwar
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
darbtejn, b’ riżultat ta ’ tnaqqis tal- medja tal- konċentrazzjonijiet ta ’ plażma mirtazapine ta ’ 60% u 45% rispettivament.
When carbamazepine or any other inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased.
Meta carbamazepine jew induttur ieħor ta ’ metaboliżmu epatiku (bħal rifampicin) huwa miżjud ma ’ terapija b’ mirtazapine, jista ’ jkun hemm bżonn ta ’ żieda fid- doża ta ’ mirtazapine.
If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.
Jekk it- trattament b’ dan il- prodott mediċinali jitwaqqaf, jista jkun hemm bżonn ta ’ tnaqqis fid- doża ta ’ mirtazapine.
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma
- Ko- amministrazzjoni tal- inibitur potenti CYP3A4 ketoconazole żied l- ogħla livelli plażma u l -
levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
AUC ta ’ mirtazapine b’ madwar 40% u 50% rispettivament.
- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with
- Meta cimetidine (impeditur dgħajjef ta ’ CYP1A2, CYP2D6 u CYP3A4) jingħata ma ’
mirtazapine, the mean plasma concentration of mirtazapine may increase more than 50%.
mirtazapine, il- medja ta ’ konċentrazzjoni tal- plażma ta ’ mirtazapine tista ’ tiżdied aktar minn 50%.
Caution should be exercised and the dose may have to be decreased when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, cimetidine or nefazodone.
Għandha tintuża attenzjoni u d- doża jista ’ jkun li jkollha titnaqqas meta mirtazapine jingħata flimkien ma ’ impedituri qawwija tas- CYP3A4, impedituri HIV tal- protease, antifungali azole, erythromycin, cimetidine jew nefazodone.
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent
- Ma ġewx osservati effetti farmakokinetiċi rilevanti fi trattament konkorrenti b’ mirtazapine ma ’
treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.
paroxetine, amitriptyline, risperidone jew litju.
Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations.
Tagħrif limitat dwar l- użu ta ’ mirtazapine f’ nisa tqal ma jurix żieda fir- riskju ta ’ malformazzjonijiet konġenitali.
Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti teratonerġiċi ta ’ rilevanza klinika, iżda ġiet osservata ħsara fuq l- iżvilupp (ara sezzjoni 5. 3).
If Remeron is used until, or shortly before birth, postnatal monitoring of the newborn is recommended to account for possible discontinuation effects.
Jekk Remeron jintuża sa, jew ftit qabel it- twelid, huwa rrakomandat li jkun hemm monitoraġġ tat- tarbija tat- twelid, sabiex wieħed jara l- effetti possibbli minħabba t- waqqif.
Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts.
Studji fuq annimali u tagħrif limitat fuq il- bniedem wrew ħruġ f’ ammonti żgħar ta ’ mirtazapine fil - ħalib tas- sider.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Remeron should be made taking into account the benefit of breast- feeding to the child and the benefit of Remeron therapy to the woman.
Għandha tittieħed deċiżjoni fuq jekk it- treddigħ għandux jitkompla/ jitwaqqaf jew jekk it- terapija għandiex titkompla/ titwaqqaf b’ Remeron billi tittieħed kunsiderazzjoni tal- benefiċċju tat - treddigħ fuq it- tarbija u l- benefiċċju tat- terapija b' Remeron fuq il- mara.
Remeron has minor or moderate influence on the ability to drive and use machines.
Remeron għandu influwenza żgħira jew moderata fuq il- ħila biex issuq u tħaddem magni.
Remeron may impair concentration and alertness (particularly in the initial phase of treatment).
Remeron jista jnaqqas il- konċentrazzjoni jew viġilanza (b’ mod partikolari fil- fażi inizzjali tat- trattament).
Patients should avoid the performance of potentially dangerous tasks, which require alertness and good concentration, such as driving a motor vehicle or operating machinery, at any time when affected.
Pazjenti għandhom jevitaw milli jagħmlu xogħlijiet potenzjalment perikolużi, li jirrikjedu viġilanza u konċentrazzjoni tajba, bħal sewqan ta ’ vettura, tħaddim ta ’ magna, fi kwalunkwe ħin meta affetwat.
Depressed patients display a number of symptoms that are associated with the illness itself.
Pazjenti b’ dipressjoni juru għadd ta ’ sintomi assoċjati mal- marda innifisha.
It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Remeron.
Għalhekk kultant huwa diffiċli li wieħed jaċċerta liema sintomi huma riżultat tal- marda stess u liema huma riżultat ta ’ trattament b’ Remeron.