natgillin/translations-raw huggingface dataset:
One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate)
Un comprimat sublingual conţine: fentanil (sub formă de citrat) 50 micrograme fentanil (sub formă de citrat) 100 micrograme fentanil (sub formă de citrat) 200 micrograme fentanil (sub formă de citrat) 300 micrograme fentanil (sub formă de citrat) 400 micrograme (sub formă de citrat) 600 micrograme fentanil (sub formă de citrat) 800 micrograme fentanil
It comes in a range of different strengths and shapes.
Poate fi disponibil într- o gamă variată de concentraţii şi forme.
The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “ D” -shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
Comprimatul de 50 micrograme este alb şi are formă pentagonală Comprimatul de 100 micrograme este alb şi rotund Comprimatul de 200 micrograme este alb şi oval Comprimatul de 300 micrograme este alb şi triunghiular Comprimatul de 400 micrograme este alb şi are formă de diamant Comprimatul de 600 micrograme este alb şi are forma literei “ D ” Comprimatul de 800 micrograme este alb şi are forma unei capsule
Not all pack sizes may be marketed.
Nu toate mărimile de ambalaj sunt disponibile pe piaţă
Marketing authorisation holder:
Deţinătorul autorizaţiei de punere pe piaţă: < [Vezi Anexa I – a se completa la nivel naţional] > {Nume şi adresă} < {telefon} >
[See Annex I - To be completed nationally] {Name and address }< {tel }> < {fax }> < {e-mail }>
39 < {fax} > < {e- mail} >
Recip AB Lagervägen 7 136 50 Haninge Sweden Tel. +46 8 6025200
Recip AB Lagervägen 7 136 50 Haninge Suedia Tel. +46 8 6025200
38 ANNEX IV
40 ANEXA IV
CONDITIONS OF THE MARKETING AUTHORISATIONS
CONDIŢIILE AUTORIZAŢIILOR DE INTRODUCERE PE PIAŢĂ
39 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
41 Autorităţile naţionale competente, coordonate de către statul membru de referinţă, vor asigura îndeplinirea următoarelor condiţii de către titularii autorizaţiei de punere pe piaţă:
The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State:
Solicitantul se angajează să furnizeze următoarele informaţii autorităţii naţionale competente a statului membru de referinţă:
Analysis of the 30% and 50% responder rates at 10 and 15 minutes for the study EN-3267- 005,
Analiza ratelor de responderi de 30% şi 50% la 10 şi 15 minute în cadrul studiului EN - o 3267- 005,
Final results of studies EN3267-005 and 3267-007, including detailed exposure of patients and full safety analysis.
Rezultatele finale ale studiilor EN- 3267- 005 şi EN- 3267- 007, inclusiv expunerea detaliată o a pacienţilor şi analiza completă a datelor de siguranţă.
London, 12 September 2008 EMEA/ CHMP/ 495857/ 2008
Londra, 12 septembrie 2008 EMEA/ CHMP/ 495853/ 2008
Rapinyl and associated names
AVIZ CA URMARE A UNEI SESIZĂRI ÎN TEMEIUL ARTICOLULUI 29 ALINEATUL (4) 1 PENTRU Rapinyl şi denumirile asociate
The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
Procedura descentralizată SE/ H/ 575/ 07/ DC a fost iniţiată la 1 septembrie 2006.
Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/ risk and the lack of PK data under normal conditions of use of the product.
Au fost identificate diferenţe semnificative referitoare la necesarul de studii clinice suplimentare de eficacitate şi siguranţă la administrare pentru evaluarea raportului beneficiu/ risc şi lipsa datelor farmacocinetice în condiţii normale de administrare a produsului.
The arbitration procedure started on 18 October 2007 with the adoption of a list of questions.
Raportor a fost Dr.
The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur.
Pierre Demolis (FR).
During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
În timpul reuniunii din iunie 2008, CHMP, prin prisma tuturor datelor înaintate şi a discuţiilor ştiinţifice din comisie, a concluzionat că raportul beneficiu/ risc este favorabil pentru Rapinyl şi denumirile asociate, că obiecţiile înaintate de Germania, Franţa, Norvegia şi Regatul Unit nu trebuie să împiedice acordarea autorizaţiei de introducere pe piaţă şi că rezumatul caracteristicilor produsului, etichetarea şi prospectul din statul membru de referinţă trebuie modificate.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAŢIILE, CĂILE DE ADMINISTRARE ALE MEDICAMENTELOR, DEŢINĂTORII AUTORIZAŢIEI DE PUNERE PE PIAŢĂ ÎN STATELE MEMBRE
1 Member State
1 Stat Membru
Marketing Authorisation INN Holder
Deţinătorul autorizaţiei de INN punere pe piaţă
Organon GesmbH Siebenbrunnengasse 21/ D/ IV
Organon GesmbH Mirtazapine Siebenbrunnengasse
Mirtazapine
21/ D/ IV Mirtazapine A- 1050 Wien
Mirtazapine
Austria Mirtazapine
Organon Europe B. V., Kloosterstraat 6, 5349AB Oss, The Netherlands
Organon Europe B. V., Mirtazapine Kloosterstraat 6,
Remergon Remergon Remergon Remergon SolTab Remergon SolTab
Remergon
15 mg 30 mg 45 mg 15 mg 30 mg
15 mg
Film-coated tablets Film-coated tablets Film-coated tablets Orodispersible tablets Orodispersible tablets
Uz oral
Oral use Oral use Oral use Oral use Oral use
5349AB Oss, Mirtazapine The Netherlands
Delegation of power:
Remergon
Organon België n. v.,
Comprimate filmate
Mirtazapine
Mirtazapine Delegation of power:
Remergon SolTab
Remergon
Terhulpsesteenweg 166, 1170 Brussels, Belgium
1170 Brussels, Mirtazapine Belgium
Remergon
Remergon Remeron
Oral solution
Soluţie orală Comprimate filmate
Oral use
Uz oral Uz oral
990 mg/ 66 ml
990 mg/ 66 ml t
C. A. Papaellinas & Co Ltd 179 Yiannos Kranidiotis Avenue, 2235 Latsia, Nicosia, Cyprus
Box
Remeron
Uz oral
Box 20, 5340 BH Oss, The Netherlands
The Netherlands
REMERON 15 MG REMERON 30 MG REMERON 45 MG REMERON SOLTAB 15 MG
REMERON 45 MG
15 mg 30 mg 45 mg 15 mg
45 mg
Film-coated tablets Film-coated tablets Film-coated tablets Orodispersible tablets
Comprimate filmate
Oral use Oral use Oral use Oral use
Uz oral
2 Member State
2 Stat Membru
IMI Pharma AS, Literbuen 9, DK- 2740 Skovlunde, Denmark
IMI Pharma AS, Mirtazapine Literbuen 9,
Mirtazapine Mirtazapine Mirtazapine
DK - 2740 Skovlunde, Mirtazapine Denmark
Orodispersible tablets Orodispersible tablets Orodispersible tablets
Comprimate orodispersabile
Oral use Oral use Oral use
Comprimate orodispersabile
Organon, Kloosterstraat 6, P. O.
Box
Box 20, 5340 BH Oss,
20, 5340 BH Oss,
Oral use Oral use Oral use
Uz oral
Film-coated tablets Film-coated tablets Film-coated tablets
Comprimate filmate
Orodispersible tablets
Mirtazapine Remeron SolTab
Orodispersible tablets Orodispersible tablets
Comprimate orodispersabile
Oral use Oral use
Uz oral
Film-coated tablets Film-coated tablets
Comprimate filmate
Oy Organon Ab
Oy Organon Ab Maistraatinportti 2
Oral Solution Film-coated tablets
Soluţie orală Comprimate filmate
Oral use Oral use
Uz oral Uz oral
3 Member State
00240 Helsinki, Finland
Strength
Comprimate orodispersabile
Pharmaceutical Form
Uz oral
Maistraatinportti 2 00240 Helsinki, Finland
Comprimate orodispersabile
Mirtazapine Mirtazapine Mirtazapine
Uz oral
Immeuble Optima 10 rue Godefroy 92821 PUTEAUX Cedex
10 rue Godefroy 92821 PUTEAUX Cedex
Film-coated tablets Film-coated tablets Orodispersible tablets
Comprimate filmate
Mirtazapine
Mirtazapine Organon GmbH Mirtazapine Mittenheimer Straße 62
Norset
Norset Remergil
85764 Oberschleißheim Germany
85764 Oberschleißheim Mirtazapine Germany
STADApharm GmbH Stadastraße 2-18
STADApharm GmbH Stadastraße 2- 18
4 Member State
Grecia
Marketing Authorisation INN Holder
Organon Hellas S. A.
Invented Name
122, Vouliagmenis Av.
Content (concentration)
Comprimate filmate
Greece
Uz oral
Mirtazapine Helliniko Mirtazapine 167 77 Athens,
Helliniko 167 77 Athens,
Orodispersible tablets Orodispersible tablets Oral Solution
Comprimate orodispersabile
Mirtazapine
Box
BoxMirtazapine 20, Mirtazapine 5340 BH Oss,
20, 5340 BH Oss,
Mirtazapine The Netherlands
The Netherlands
Remeron Remeron
Comprimate orodispersabile
Ireland
Uz oral
Remeron Zispin® tablets
Mirtazapine Remeron 15 mg/ ml
15 mg/ ml film-coated
15 mg/ ml
15 mg/ ml 15 mg
Soluţie orală
Milton Road, CB4 0FL, Mirtazapine United Kingdom
Organon Laboratories Ltd, Cambridge Science Park,
Zispin® tablets
Mirtazapine Zispin® film - coated tablets
film-coated
Comprimate filmate
Organon (Ireland) Limited, Mirtazapine
Organon (Ireland) Limited,
Soltab®
Zispin® Soltab®
PO Box 2857,
PO Box 2857, Drynam Road,
Oral solution
Soluţie orală Comprimate orodispersabile
15 mg 30 mg 45 mg 15 mg 30 mg 45 mg
30 mg
Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets Orodispersible tablets
45 mg
Oral use Oral use Oral use Oral use Oral use Oral use
Comprimate orodispersabile
Latvia
Uz oral
Box 20, NL 5340 AB Oss,
Comprimate orodispersabile
30 mg 15 mg 30 mg
30 mg
Film-coated tablets Orodispersible tablets Orodispersible tablets
Deţinătorul autorizaţiei de INN punere pe piaţă
Oral use Oral use Oral use
Formă farmaceutică
The Netherlands
Cale de administrare
Organon, Kloosterstraat 6, P. O.
Organon, Mirtazapine Kloosterstraat 6, P. O.
Orodispersible tablets
Mirtazapine Remeron
Marketing Authorisation INN Holder
Comprimate orodispersabile
Invented Name
The Netherlands
Strength
30 mg
Pharmaceutical Form
Comprimate orodispersabile
Content (concentration)
Comprimate orodispersabile
Kloosterstraat 6, 5349AB Oss,
Kloosterstraat 6,
Mirtazapine Mirtazapine Mirtazapine
Mirtazapine Remergon
Remergon SolTab Remergon SolTab
Mirtazapine Remergon SolTab 15
15 mg 30 mg
mg
Organon België n. v.,
1170 Brussels, Belgium
Mirtazapine
Mirtazapine Remergon SolTab 30
Remergon SolTab
Comprimate orodispersabile
45 mg
Mirtazapine Remergon SolTab 45
Terhulpsesteenweg 166, 1170 Brussels, Belgium
Comprimate orodispersabile
Mirtazapine
Uz oral
Netherlands
8 Stat Membru
Orodispersible Tablets Orodispersible Tablets Orodispersible Tablets Orodispersible Tablets
Comprimate orodispersabile
15 mg per tablet 30 mg per tablet 45 mg per tablet 15 mg per tablet
Comprimate orodispersabile
Orodispersible Tablets
Comprimate orodispersabile
Remeron Remeron Remeron-S smeltetabletter
Remeron
Oral use Oral use Oral use
Comprimate filmate
Member State
Uz oral
The Netherlands
Uz oral
30 mg per tablet
Concentraţie
Portugal
Uz oral
José Malhoa, 16-B -2º
1070- 159 Lisboa Portugal
1070-159 Lisboa
Uz oral
Orodispersible tablets Orodispersible tablets Oral solution
Comprimate orodispersabile
Oral use Oral use Oral use
Soluţie orală
Aacifar Produtos Químicos e Farmacêuticos, Lda Av.
Aacifar Produtos Químicos e
Romania
Uz oral
Organon, Kloosterstraat 6, P. O.
Farmacêuticos, Lda Av.
Box
José Malhoa, 16- B - 2º
Remeron SolTab 15 15 mg mg
30 mg
20, 5340 BH Oss,
1070- 159 Lisboa Portugal
Remeron SolTab 30 30 mg mg
45 mg
8 Member State
10 Stat Membru
The Netherlands
Remeron SolTab 15 mg
Mirtazapine
20, Mirtazapine 5340 BH Oss,
Remeron mg
Remeron SolTab 30 mg
Box 20, 5340 BH Oss,
20, Mirtazapine 5340 BH Oss,
Mirtazapine Mirtazapine Mirtazapine
Comprimate filmate
REMERON REMERON REMERON
The Netherlands Mirtazapine
15 mg 30 mg 45 mg
REMERON 45 mg
Rexer Rexer Rexer
Mirtazapine Rexer
Film coated tablets Film coated tablets Film coated tablets
Comprimate filmate
Mirtazapine
Mirtazapine Rexer
Orodispersible tablets
Comprimate filmate
Llobregat Barcelona, Spain N. V.
Spain
Rexer Flas Rexer Flas Rexer Mirtazapina Organon Mirtazapina Organon Mirtazapina Organon
Mirtazapine Rexer Flas
30 mg 45 mg 15 mg/ ml 15 mg 30 mg 45 mg
15 mg
990 mg/ 66 ml
Uz oral
Sweden
Mirtazapine Rexer Flas
Box 20, NL - 5340 BH Oss, The Netherlands
Comprimate orodispersabile
Remeron Remeron Remeron
Mirtazapine Rexer Flas
Tablets Tablets Tablets
Comprimate orodispersabile
Mirtazapine Mirtazapine
Mirtazapine Rexer
Oral solution Orodispersible tablets
Soluţie orală
9 Member State
11 Stat Membru
Orodispersible tablets Orodispersible tablets Tablets
Comprimate orodispersabile
Oral use Oral use Oral use
20, 5340 BH Oss,
Tablets
Uz oral
Oral use
The Netherlands
Tablets
Comprimate orodispersabile
Organon Laboratories Ltd, Cambridge Science Park,
Box
Mirtazapine 15mg Tablets
Remeron
Milton Road, Cambridge, CB4 0FL
20, 5340 BH Oss,
Mirtazapine 30mg Tablets
Remeron
United Kingdom
The Netherlands
Mirtazapine 45mg Tablets
Remeron
Oral Solution
Soluţie orală Comprimate orodispersabile
Zispin SolTab 15mg orodispersible tablet
Comprimate orodispersabile
Mirtazapine
Mirtazapine Mirtazapin IP
45 mg per tablet
Regatul Unit al Marii Britanii
10 ANNEX II
Mirtazapine
SCIENTIFIC CONCLUSIONS AND GROUNDS PRESENTED BY THE EMEA
Mirtazapine 15mg 15 mg Tablets
11 SCIENTIFIC CONCLUSIONS
Comprimate filmate
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF REMERON AND ASSOCIATED NAMES (SEE ANNEX I)
Milton Road, Cambridge, CB4 0FL
Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ ml
Mirtazapine 30mg 30 mg Tablets
The SPC proposals by the company were mainly based upon this MRP.
Comprimate filmate
Further the recommendations by the Pharmacovigilance Working Party with respect to the core SPC for antidepressants were implemented.
Uz oral
SPC Section 4.1 Therapeutic Indications
United Kingdom
In section 4.1 Therapeutic Indications of the SPC, the CHMP considered that the indication should be amended to:
Mirtazapine
SPC Section 4.2 Posology and Method of Administration
Mirtazapine 45mg 45 mg Tablets
The proposal was adopted by the applicant/ MAH and the issue was resolved.
Comprimate filmate
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).
Uz oral
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).
12 Stat Membru
That is the reason for the cut-off value of 40 ml/ min/ 1.73 m2.
Deţinătorul autorizaţiei de INN punere pe piaţă
This FDA Guidance was superseded in 1998.
Concentraţie
SPC Section 4.3 Contraindications
Formă farmaceutică
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.
Cale de administrare
These do not include hereditary deficiencies of amino acid (phenylalanine) metabolism, such as phenylketonuria.
Conţinut (concentraţie)
Since it is indicated in the Annex that aspartame, containing a source of phenylalanine may be harmful for people with phenylketonuria (and no comment is included in the Annex that a contraindication should be included in the SPC, such as done for peanut oil), this is not considered to be an absolute contraindication.
Mirtazapine
The amount of phenylalanine is low in Remeron orodispersible tablets.
Mirtazapine 15mg/ ml Oral Solution
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
15 mg/ ml
The warning at section 4.5 seems sufficient for its purpose.
Soluţie orală
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.
Uz oral
Pathological alterations of blood count The applicant/ MAH stated that there are no data indicating that mirtazapine aggravates conditions where blood count is altered.
990 mg/ 66 ml
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.
Mirtazapine
SPC Section 4.5 Special Warnings and precautions for use
Zispin SolTab 15mg orodispersible tablet
The low number of post-marketing reports does not justify this either.
Comprimate orodispersabile
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.
Uz oral
Pharmacodynamic interactions Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Mirtazapine
Therefore, the following wording on pharmacodynamic interactions for Section 4.5 of the SPC was recommended:
Zispin SolTab 30mg orodispersible tablet
Pharmacodynamic interactions
Comprimate orodispersabile
- Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks
Mirtazapine
after discontinuation of MAO inhibitor therapy.
Zispin SolTab 45mg orodispersible tablet
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors.
45 mg
- In addition, as with SSRIs, co-administration with other serotonergic active substances (L-
Comprimate orodispersabile
tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St.
CONCLUZII ŞTIINŢIFICE ŞI MOTIVE PREZENTATE DE CĂTRE EMEA
14
14 CONCLUZII ŞTIINŢIFICE
- Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably
REZUMATUL GENERAL AL EVALUĂRII ŞTIINŢIFICE PENTRU REMERON ŞI DENUMIRILE ASOCIATE (VEZI ANEXA I)
most antipsychotics, antihistamine H1 antagonists, opioids).
Remeron (mirtazapin) a fost înaintat pentru armonizarea rezumatului caracteristicilor produsului, în conformitate cu articolul 30 alineatul (1) al Directivei 2001/ 83/ CE.
Caution should be exercised when these medicinal products are prescribed together with mirtazapine.
Mirtazapin este indicat pentru episoadele de depresie majoră.
Patients should therefore be
Remeron comprimate de 15, 30 şi 45 mg Remeron comprimate orodispersabile de 15, 30 şi 45 mg Remeron soluţie orală de 15 mg/ ml
advised to avoid alcoholic beverages while taking mirtazapine. monitoring for signs of beginning serotonergic overstimulation maintained is warranted.
Propunerile societăţii privind rezumatul caracteristicilor produsului au fost în principal bazate pe această procedură de recunoaştere reciprocă.
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the
Următoarele secţiuni din informaţiile referitoare la produs au fost dezbătute în timpul procedurii de armonizare.
international normalized ratio (INR) in subjects treated with warfarin.
Rezumatul caracteristicilor produsului secţiunea 4. 1 Indicaţii terapeutice
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.
În secţiunea 4. 1 Indicaţii terapeutice din rezumatul caracteristicilor produsului, Comitetul pentru produse medicamentoase de uz uman (CHMP) a considerat că indicaţia ar trebui modificată în:
Finally, the cimetidine interaction study should be included in section 4.5.
Episoade de depresie majoră (sau tratamentul episoadelor de depresie majoră) în conformitate cu formularea agreată pentru această indicaţie pentru alte produse la care rezumatul caracteristicilor produsului este armonizat în Europa.
Pharmacokinetic interactions.
CHMP a considerat că adăugarea termenului „ la adulţi ” nu este acceptabilă.
Therefore the following wording was recommended:
Această propunere a fost adoptată de către solicitant/ titularul autorizaţiei de introducere pe piaţă şi astfel problema a fost rezolvată.
Pharmacokinetic interactions
Rezumatul caracteristicilor produsului secţiunea 4. 2 Doze şi mod de administrare
- Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about
Această propunere a fost adoptată de către solicitant/ titularul autorizaţiei de introducere pe piaţă şi astfel problema a fost rezolvată.
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
În plus, CHMP a considerat că clearance- ul mirtazapinului poate fi scăzut la pacienţii cu insuficienţă renală moderată până la severă (clearance- ul creatininiei < 40 ml/ min).
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.
Acest lucru trebuie luat în considerare atunci când se prescrie Remeron acestei categorii de pacienţi (vezi secţiunea 4. 4).
If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.
Prin urmare solicitantului/ titularului autorizaţiei de introducere pe piaţă i s- a solicitat să asigure sprijin pentru întreruperea tratamentului la o valoare de 40 ml/ min deoarece intervalul normal este între 30- 50 ml/ min (insuficienţă renală moderată).
- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma
În acest studiu, subiecţii au fost împărţiţi în 4 categorii folosind următoarele valori de întrerupere:
levels and the AUC of mirtazapine by approximately 40% and 50% respectively.
Acesta este motivul pentru valoarea de întrerupere de 40 ml/ min/ 1, 73 m2.
Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin or nefazodone.
În plus, cea mai recentă recomandare a Uniunii Europene a fost stabilită în 1994 (Notă pentru recomandarea evaluării farmacocineticii produselor medicamentoase la pacienţii cu insuficienţă renală, CHMP/ EWP/ 225/ 02).
- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with
Rezumatul caracteristicilor produsului secţiunea 4. 3 Contraindicaţii
mirtazapine, the mean plasma concentration of mirtazapin may increase more than 50%.
Totuşi, CHMP nu a considerat această explicaţie acceptabilă şi a cerut solicitantului/ titularului autorizaţiei de introducere pe piaţă să ofere argumente pentru neconsiderarea acestor contraindicaţii ca absolute.
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.
CHMP a fost de părere că fenilcetonuria, inhibitorii de monoaminooxidază (IMAO) şi modificările patologice ale numărului de celule sanguine sunt considerate contraindicaţii absolute.
- No significant pharmacokinetic interactions are expected between mirtazapine and other
Acestea nu includ deficienţele ereditare ale metabolismului aminoacizilor (fenilalanină), cum ar fi fenilcetonuria.