natgillin/translations-raw huggingface dataset:
Aacifar Produtos Químicos e Farmacêuticos, Lda Av.
Organon Portuguesa Produtos Químicos e Farmacêuticos, Lda
Mirtazon Mirtazon Mirtazon
Mirtazapina Organon
Orodispersible tablets Orodispersible tablets Orodispersible tablets
Õhukese polümeerikatteg a tabletid
Romania
Av.
Organon, Kloosterstraat 6, P. O.
Mirtazapina Organon
Box
30 mg
Remeron SolTab 15 15 mg mg
Remeron
Orodispersible tablets
45 mg
Oral use
Õhukese polümeerikatteg a tabletid
20, 5340 BH Oss,
Suukaudne
Remeron SolTab 30 30 mg mg
Remeron SolTab
Pharmaceutical Form
Remeron SolTab
Route of administration
30 mg
Content (concentration)
Suus dispergeeruvad tabletid
Remeron mg
Remeron SolTab
SolTab 45
45 mg
Slovak Republic
13 Liikmesriik
N. V.
INN
Organon, Kloosterstraat 6, P. O.
Väljamõeldud nimetus
Box 20, 5340 BH Oss,
Manustamistee
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Mirtazon
REMERON REMERON REMERON
Mirtazapine Mirtazon
Film-coated tablets Film-coated tablets Film-coated tablets
Suus dispergeeruvad tabletid
REMERON 15 mg
Remeron SolTab 15 mg
REMERON 30 mg
Remeron SolTab 30 mg
REMERON 45 mg
Remeron SolTab 45 mg
Ctra.
N. V.
Box 20, 5340 BH Oss, The Netherlands
Box 20,
30 mg 45 mg 15 mg/ ml 15 mg 30 mg 45 mg
Mirtazapine REMERON 15 mg 15 mg
Oral use Oral use Oral use Oral use Oral use Oral use
Õhukese polümeerikatteg a tabletid
Box 20, NL - 5340 BH Oss, The Netherlands
5340 BH Oss, The Netherlands
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine REMERON 30 mg 30 mg
Remeron Remeron Remeron
Õhukese polümeerikatteg a tabletid
15 mg 30 mg 45 mg
REMERON 45 mg 45 mg
Tablets Tablets Tablets
Õhukese polümeerikatteg a tabletid
Mirtazapine Mirtazapine
Mirtazapine
15 mg/ ml 15 mg
REMERON Soltab 15 mg 15 mg
Oral solution Orodispersible tablets
Suus dispergeeruvad tabletid
990 mg/ 66 ml
14 Liikmesriik
9 Member State
Müügiloa hoidja
Marketing Authorisation INN Holder
INN
30 mg 45 mg 15 mg
REMERON Soltab 30 mg
Tablets
Suus dispergeeruvad tabletid
MirtazapinImi Pharma
REMERON Soltab 45 mg
United Kingdom
Hispaania
Organon Laboratories Ltd, Cambridge Science Park,
De Hospitalet, 147 -
Mirtazapine 15mg Tablets
Rexer
Film-coated tablets
Film coated tablets
Milton Road, Cambridge, CB4 0FL
149 Cityparc Ronda de Dalt Edificio Amsterdam
Mirtazapine 30mg Tablets
Rexer
United Kingdom
08940 Cornellá de Llobregat Barcelona,
Mirtazapine 45mg Tablets
Rexer
Mirtazapine
Spain
Mirtazapine 15mg/ ml Oral Solution
Mirtazapine
990 mg/ 66 ml
Rexer Flas
Zispin SolTab 30mg orodispersible tablet
Rexer Flas
Zispin SolTab 45mg orodispersible tablet
Rexer Flas
10 ANNEX II
N. V.
SCIENTIFIC CONCLUSIONS AND GROUNDS PRESENTED BY THE EMEA
Box 20,
11 SCIENTIFIC CONCLUSIONS
Mirtazapine Mirtazapine
Mirtazapine is indicated for episodes of major depression.
Rexer Mirtazapina Organon
Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ ml
15 mg/ ml 15 mg
The SPC proposals by the company were mainly based upon this MRP.
Suukaudne lahus Suus dispergeeruvad tabletid
SPC Section 4.1 Therapeutic Indications
Suukaudne Suukaudne
In section 4.1 Therapeutic Indications of the SPC, the CHMP considered that the indication should be amended to:
990 mg/ 66 ml
SPC Section 4.2 Posology and Method of Administration
5340 BH Oss, The Netherlands
The proposal was adopted by the applicant/ MAH and the issue was resolved.
Mirtazapine
Additionally, the CHMP considered that the clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
Mirtazapina Organon
To investigate the impact of renal impairment on the pharmacokinetics of mirtazapine, the applicant/ MAH made reference to a clinical trial that was designed specifically for that purpose (trial 22503).
30 mg
This FDA Guidance was superseded in 1998.
Suus dispergeeruvad tabletid
SPC Section 4.3 Contraindications
Suukaudne
The applicant/ MAH restricted the contra-indication to hypersensitivity only, in accordance with the EC Guideline on SPC, as only absolute contraindications should be mentioned and relative contra- indications should move to the warning section 4.3 or section.
Mirtazapine
The amount of phenylalanine is low in Remeron orodispersible tablets.
Mirtazapina Organon
The CHMP considered that the explanations provided appear scientifically sound and justified, noting that the aspartame content of the product is adequately addressed in the proposed form
45 mg
The warning at section 4.5 seems sufficient for its purpose.
Suus dispergeeruvad tabletid
13 The CHMP considered that a contraindication is acceptable, given the marginal influence on noradrenaline and serotonin levels and the post-marketing experience available to date.
Suukaudne
Pathological alterations of blood count The applicant/ MAH stated that there are no data indicating that mirtazapine aggravates conditions where blood count is altered.
15 Liikmesriik
With regards to the pathological alterations of blood count, the CHMP considered that proposed wording is acceptable, based on the meta-analysis report provided in the applicant/ MAH’ s responses.
Müügiloa hoidja
SPC Section 4.5 Special Warnings and precautions for use
INN
The low number of post-marketing reports does not justify this either.
Väljamõeldud nimetus
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.
Tugevus
Pharmacodynamic interactions Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Ravimvorm
Therefore, the following wording on pharmacodynamic interactions for Section 4.5 of the SPC was recommended:
Manustamistee
Pharmacodynamic interactions
Sisu (kontsentratsioon)
- Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks
Rootsi
after discontinuation of MAO inhibitor therapy.
Organon, Kloosterstraat 6, P. O.
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors.
Box 20,
tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St.
Mirtazapine Remeron
14
15 mg
- Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably
Õhukese polümeerikatteg a tabletid
most antipsychotics, antihistamine H1 antagonists, opioids).
5340 BH Oss, The Netherlands
- Mirtazapine may increase the CNS depressant effect of alcohol.
Mirtazapine Remeron
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the
30 mg
international normalized ratio (INR) in subjects treated with warfarin.
Õhukese polümeerikatteg a tabletid
Pharmacokinetic interactions.
Suukaudne
Pharmacokinetic interactions
Mirtazapine Remeron
- Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about
45 mg
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
Õhukese polümeerikatteg a tabletid
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma
Suukaudne
levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
Mirtazapine Remeron Mirtazapine Remeron- S
Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin or nefazodone.
15 mg/ ml 15 mg
- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with
Suukaudne lahus Suus dispergeeruvad tabletid
mirtazapine, the mean plasma concentration of mirtazapin may increase more than 50%.
Suukaudne Suukaudne
- No significant pharmacokinetic interactions are expected between mirtazapine and other
990 mg/ 66 ml
Mirtazapine does not significantly inhibit or induce CYP iso-enzymes.
Mirtazapine Remeron- S
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent
30 mg
treatment of mirtazapine with paroxetine, amitriptyline, or risperidone or lithium.
Suus dispergeeruvad tabletid
A single dose of mirtazapine does not result in any acute effect on the pharmacokinetics of lithium at steady state.
Suukaudne
SPC 4.8 Undesirable Effects
Mirtazapine Remeron- S
This proposal was adopted by the applicant/ MAH and the issue was resolved.
Suus dispergeeruvad tabletid
Package Leaflet
Suukaudne
The following amendments to the PIL were recommended, in line with the changes made to the SPC.
Mirtazapine Mirtazapin IP
15 a.
15 mg
BEFORE YOU TAKE REMERON
Õhukese polümeerikatteg a tabletid
Do not take Remeron while you are pregnant.
Mirtazapine Mirtazapin IP
b.
30 mg
Johns Wort – Hypericum perforatum preparations (a herbal remedy for depression).
Õhukese polümeerikatteg a tabletid
In very rare cases Remeron alone or the combination of Remeron with these medicines, can lead to a so-called serotonin syndrome.
Suukaudne
If you get a combination of these symptoms, talk to your doctor immediately.
Mirtazapine Mirtazapin IP
The CHMP considered that the proposed wording under bullet point a and b were acceptable.
Õhukese polümeerikatteg a tabletid
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Suukaudne
Whereas
Ühendkuningrii k
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
Organon Laboratories Ltd, Cambridge Science Park, Milton Road,
labelling, package leaflet and Module 3.
Mirtazapine
- the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the
Mirtazapine 15mg 15 mg Tablets
Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Õhukese polümeerikatteg a tabletid
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).
Suukaudne
16 ANNEX III
16 Liikmesriik
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Müügiloa hoidja
17 SUMMARY OF PRODUCT CHARACTERISTICS
Väljamõeldud nimetus
18 1.
Tugevus
NAME OF THE MEDICINAL PRODUCT
Sisu (kontsentratsioon)
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
Mirtazapine
[See Annex I - To be completed nationally]
Mirtazapine 30mg
2.
30 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
United Kingdom
Each Remeron 15 mg orodispersible tablet contains 15 mg of mirtazapine.
polümeerikatteg a tabletid
Each Remeron 30 mg orodispersible tablet contains 30 mg of mirtazapine.
Mirtazapine 45mg Tablets
Each Remeron 45 mg orodispersible tablet contains 45 mg of mirtazapine.
Õhukese polümeerikatteg a tabletid
Excipients:
Mirtazapine
For a full list of excipients, see section 6.1.
Mirtazapine 15mg/ ml Oral Solution
3.
15 mg/ ml
PHARMACEUTICAL FORM
Suukaudne lahus
Orodispersible tablet.
Zispin SolTab 15mg orodispersible tablet
15 mg orodispersible tablet:
15 mg
Round, white, standard bevelled-edge, coded with ‘ TZ/ 1’ on one side.
Zispin SolTab 30mg orodispersible tablet
30 mg orodispersible tablet:
30 mg
Round, white, standard bevelled-edge, coded with ‘ TZ/ 2‘ on one side.
Zispin SolTab 45mg orodispersible tablet
45 mg orodispersible tablet:
45 mg
Round, white, standard bevelled-edge, coded with ‘ TZ/ 4’ on one side.
Suus dispergeeruvad tabletid
CLINICAL PARTICULARS
Suukaudne
4.1 Therapeutic indications
17 II LISA
Treatment of episodes of major depression.
EUROOPA RAVIMIAMETI ESITATUD TEADUSLIKUD PÕHJENDUSED NING PÕHJENDUSED
4.2 Posology and method of administration
18 TEADUSLIKUD JÄRELDUSED
With an insufficient response, the dose can be increased up to the maximum dose.
REMERONI JA SEOTUD NIMETUSTE (VT I LISA) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
Elderly The recommended dose is the same as that for adults.
Mirtasapiin on näidustatud raske depressiooni raviks.
In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
Esildise tegi taotleja ja selle eesmärk on ühtlustada liikmesriikidevahelisi erinevusi järgmiste mirtasapiini toimeainena sisaldavate toodete ravimi omaduste kokkuvõtetes, pakendi infolehtedes, märgistuses ja moodul 3- s:
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).
Remeron tabletid 15, 30 ja 45 mg Remeron suus lahustuvad tabletid 15, 30 ja 45 mg Remeron suukaudselt kasutatav lahus 15 mg/ ml
19 Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
14. veebruaril 2007 kiideti vastastikuse tunnustamise menetlusel heaks ühine müügiloa pikendamine järgmiste ravimite puhul:
This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
Remeron õhukese polümeerikattega tabletid 45 mg, Remeron 15, 30, 45 mg, Remeron suukaudselt kasutatav lahus 15 mg/ ml, Mirtazapine suus lahustuvad tabletid 15, 30, 45 mg.
Hepatic impairment The clearance of mirtazapine may be decreased in patients with hepatic impairment.
Pikendamine hõlmas kokku 8 liikmesriiki, sealhulgas viiteliikmesriiki.
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).
Ettevõtte poolt esitatud ravimi omaduste kokkuvõte alased ettepanekud põhinesid peamiselt kõnealusel vastastikuse tunnustamise menetlusel.
Mirtazapine has an elimination half-life of 20-40 hours and therefore Remeron is suitable for once daily administration.
Rakendati ravimiohutuse järelevalve töörühma soovitusi antidepressantide ravimiomaduste kokkuvõtte põhiosa suhtes.
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).
Ravimi omaduste kokkuvõtted, mille kohta esildis tehti, vaadati läbi lähtuvalt Euroopa Komisjoni 2005. aasta juhendist ravimi omaduste kokkuvõtete kohta.
The tablet will rapidly disintegrate and can be swallowed without water.
Kõnealuse ühtlustamismenetluse jooksul käsitleti järgmisi ravimi omaduste kokkuvõtte punkte:
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Ravimi omaduste kokkuvõtte punkt 4. 1 Näidustused
It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).
Raske depressioon (või raske depressiooni ravi) kooskõlas kõnealuse näidustusega muude ravimite Euroopas ühtlustatud ravimi omaduste kokkuvõtetega.
Hypersensitivity to the active substance or to any of the excipients.
Inimravimite komitee leidis, et lisandus „ täiskasvanutel ” ei ole vastuvõetav.
Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
Taotleja/ müügiloa hoidja kiitis ettepaneku heaks ja kõnealune küsimus lahendati.
4.4 Special warnings and precautions for use
Ravimi omaduste kokkuvõtte punkt 4. 2 Annustamine ja manustamisviis
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Ravimi omaduste kokkuvõtte punkti 4. 2 Annustamine ja manustamisviis puhul leidis inimravimite komitee, et lause „ Kui patsiendil kaebused puuduvad, jätkatakse ravi veel 4... 6 kuu jooksul ” tuleks asendada lausega „ Depressiooni diagnoosiga patsiente peab ravima piisavalt kaua, vähemalt 6 kuud, sümptomite täieliku kadumiseni. ” (kooskõlas teiste antidepressantide sõnastusega).
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Taotleja/ müügiloa hoidja kiitis ettepaneku heaks ja kõnealune küsimus lahendati.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Lisaks leidis inimravimite komitee, et mirtasapiini kliirens võib mõõduka kuni raske neerupuudulikkusega patsientidel olla vähenenud.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Seda tuleks kõnealusele patsientide kategooriale Remeroni välja kirjutades arvesse võtta (vt punkt 4. 4).
Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or
Taotlejal/ müügiloa hoidjal paluti seetõttu esitada toetavaid andmeid läve 40 ml/ min kohta, sest tavaline määratletud vahemik on 30– 50 ml/ min (mõõdukas neerupuudulikkus).
20 thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Mirtasapiini farmakokineetika uurimiseks neerupuudulikkusega patsientidel viitas taotleja / müügiloa hoidja just selle eesmärgiga toimunud kliinilisele uuringule (uuring 22503).
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.
Kõnealuses uuringus jaotati uuringualused 4 kategooriasse vastavalt järgmistele lävedele.
Bone marrow depression Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Remeron.
19 Sel ajal, 1989. aastal olid neerupuudulikkuse läved kooskõlas toidu - ja ravimiameti juhendiga „ Farmakokineetika ja farmakodünaamika häiritud neerufunktsiooniga patsientidel: uuringu ülesehitus, andmete analüüs ning mõju annustamisele ja märgistusele ”.
Reversible agranulocytosis has been reported as a rare occurrence in clinical studies with Remeron.
Toidu - ja ravimiameti juhendid asendati 1998. aastal.
In the postmarketing period with Remeron very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal.
Lisaks kehtestati kõige viimased ELi juhendid 1994. aastal (märkus ravimite farmakokineetika hindamise juhendite juurde häiritud neerufunktsiooniga patsientidel CHMP/ EWP/ 225/ 02).
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.
Neerupuudulikkusega patsiendid ja nende raviarstid peaksid olema teadlikud asjaolust, et neerupuudulikkusega patsientide puhul võib kokkupuude mirtasapiiniga olla tugevam ning et neerupuudulikkuse raskusastme ja kokkupuute vahel on positiivne korrelatsioon.
Jaundice Treatment should be discontinued if jaundice occurs.
Ravimi omaduste kokkuvõtte punkt 4. 3 Vastunäidustused
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.
Taotleja / müügiloa hoidja jättis kooskõlas Euroopa Komisjoni ravimi omaduste kokkuvõtete juhenditega vastunäidustustesse alles ainult ülitundlikkuse, kuna ära tuleb märkida ainult absoluutsed vastunäidustused ja suhtelised vastunäidustused tuleks esitada punktis 4. 3 Hoiatused või punktis.
Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency – hepatic impairment:
Kuid inimravimite komitee ei pidanud kõnealust selgitust vastuvõetavaks ja palus taotlejal/ müügiloa hoidjal põhjendada, miks kõnealused vastunäidustused ei ole absoluutsed.
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.
Inimravimite komitee oli seisukohal, et fenüülketonuuria, MAO inhibiitorid ja kliinilise vere väärtuste patoloogilised muutused on absoluutsed vastunäidustused.
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.
Fenüülketonuuria Taotleja/ müügiloa hoidja väitis, et vastavalt ravimi omaduste kokkuvõtete juhendile (2005. aasta oktoober) tuleb ära märkida vastunäidustused teatavate abiainete puhul (vastavalt inimravimite abiainete märgistusele ja pakendi infolehele kandmise juhendile).
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:
Ravimi müügiloa taotluses esitatud abiainete juhend (EMEA/ CHMP/ QWP/ 396951/ 2006) ja eespool osutatud juhendid (CHMP/ 463/ 00) osutavad, millised abiained ja milline teave peavad olema märgistusele kantud.
In patients with diabetes, antidepressants may alter glycaemic control.
Lisas on sõnaselgelt märgitud need abiained, mis on vaja vastunäidustustesse kanda (nt ülitundlikkus maapähkli - või sojaõli vastu).
Insulin and/ or oral hypoglycaemic dosage may need to be adjusted and close monitoring is recommended.
Vastunäidustused ei hõlma pärilikke aminohapete (fenüülalaniini) ainevahetuse häireid nagu fenüülketonuuria.
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.
Kuna lisas on märgitud, et aspartaam, mis on fenüülalaniini allikas, võib olla fenüülketonuuriaga inimestele kahjulik (ning lisas ei ole esitatud märkust, et ravimi omaduste kokkuvõttesse tuleb kanda vastunäidustus, nagu maapähkliõli puhul), siis ei peeta seda absoluutseks vastunäidustuseks.
Patients with a history of mania/ hypomania should be closely monitored.
Remeron suus lahustuvate tablettide fenüülalaniini sisaldus on väike.
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.
Fenüülalaniinile tundlikud inimesed püüavad enamasti säilitada madalat fenüülalaniini taset (nt toitumise abil), mitte ei väldi kõnealust ainet täies ulatuses.
The majority of withdrawal reactions are mild and self-limiting.
Aspartaami kasutamine kõnealustes kogustes Remeron suus lahustuvates tablettides ei ole absoluutne vastunäidustus.
Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported.
Seetõttu tehakse ettepanek säilitada kõnealune hoiatus vastavas punktis 4. 4.
Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease.
Aspartaam võib olla/ on lastele vastunäidustatud, kuid mirtasapiin ei ole ette nähtud kõnealuses vanuserühmas kasutamiseks ja seetõttu pole täiendavat hoiatust vaja.
As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually.
Inimravimite komitee leidis, et esitatud selgitused on teaduslikult põhjendatud ja õigustatud ning märkis, et ravimi aspartaamisisaldus on asjakohases vormis esitatud.